Prospective Study of 18F-AlF-NOTA-Octreotide PET-CT or PET-MR in Diagnosis, Treatment and Prognosis for Neuroendocrine Neoplasms
Conditions: Neuroendocrine Tumors
Sponsor: First Affiliated Hospital of Zhejiang University

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Protocol Title 
Prospective study of 18F-AlF-NOTA-Octreotide PET-CT or PET-MR in 
diagnosis, treatment and prognosis for Neuroendocrine Neoplasms 
Version Information 
Version Number: 2.0 
Release Date: November 16, 2024 
Research Institution: The First Affiliated Hospital, Zhejiang University School of 
Medicine 
Principal Investigator: Chen Donghe 
________________________________________ 
Protocol Amendment History 
Version 
Date Revision Summary 
1.0 
2024-09-07 Initial Draft 
2.0 
2024-11-16 Revision 1 
________________________________________ 
 
Protocol Synopsis 
Item 
Details 
Study Title 
18F-Octreotide PET/CT or PET/MR for Diagnosis, Therapeutic Response, and 
Prognosis in Neuroendocrine Neoplasms 

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Item 
Details 
Design 
Prospective, single-center, cross-sectional study 
Centers 
1 
Sample Size 
152 
Indication 
Patients with suspected/confirmed NEN 
Objective 
Evaluate diagnostic efficacy, therapeutic response assessment, and prognostic 
prediction of 18F-Octreotide PET/CT or PET/MR using pathology as the gold 
standard. 
Primary 
Endpoint 
Completion of multimodal imaging + pathological confirmation 
Inclusion 
Criteria 
1. Clinical diagnosis of neuroendocrine neoplasms;2.Supected of neuroendocrine 
neoplasms 
Exclusion 
Criteria 
1. Inability to undergo biopsy/surgery.<br>2. Active malignancy/history within 5 
years.<br>3. Severe uncontrolled comorbidities/active infection.<br>4. Unable to 
provide informed consent. 
Termination 
Criteria 
1. Study objectives met.<br>2. Occurrence of SAEs. 
18F-Octreotide 
QC 
Produced per Chinese Pharmacopoeia; passed rodent safety studies; facility holds 
Type IV Radioactive Pharmaceutical License. 
Follow-up Plan 
Internal patients: Data extracted from electronic medical records.<br>External 
patients: Telephone follow-up for pathological results. 
Analysis Plan 
SPSS 17.0 for:<br>- Sensitivity/specificity/NPV/PPV (2×2 tables)<br>- AUC/optimal 
SUV cutoff (ROC curves)<br>- Kappa test (imaging vs. pathology concordance)<br>- 
Significance: p<0.05 

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Item 
Details 
Quality 
Management 
AE surveillance system; anonymized data storage; regulatory audit compliance; no 
identifiable data in publications. 
Abbreviations 
Abbreviation 
Full Term 
PET 
Positron Emission Tomography 
CT 
Computed Tomography 
ROC 
Receiver Operating Characteristic Curve 
SSTR 
Somatostatin Receptors 
 
1. Research Background 
Neuroendocrine neoplasms (NEN) are heterogeneous tumors. Neuroendocrine cells 
are distributed throughout multiple organs and tissues, enabling NEN to arise in 
various sites, commonly the gastrointestinal tract, pancreas, and lungs. Symptoms may 
relate to hormone secretion and bioactive peptides entering systemic circulation [1]. 
Beyond these sites, NEN can also occur in other endocrine organs (e.g., thymus, 
adrenal glands, pituitary, thyroid, and parathyroid). Over the past decade, NEN 
incidence and prevalence have increased [2]. Amidst the rise of precision oncology, 
solid tumor treatment has entered an era dominated by genetic testing and targeted 
therapy. Although NEN incidence is growing, treatment selection and prognosis 
prediction rely on clinicopathological factors (staging, grading, differentiation), 
lacking precision biomarkers or assays for guiding therapy. 

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Ultrasound, CT, and MRI—common imaging modalities—struggle to accurately 
diagnose and assess NEN. Thus, a highly sensitive diagnostic tool is urgently needed 
to address clinical demands. 
Nuclear medicine plays a fundamental role in NEN diagnosis and research, 
particularly in somatostatin receptor (SSTR) imaging. As most NEN express SSTR, 
SSTR analogs serve as targets for radionuclide imaging [3]. 111In-DTPA-D-Phe1-
octreotide (Octreoscan) SPECT is a classic method for diagnosing SSTR-positive 
NEN [4]. However, ({68})Ga-labeled DOTA-SSTR PET/CT (e.g., DOTA-Tyr(^3)-
octreotate [DOTATATE], DOTA-Nal(^3)-octreotide [DOTA-NOC], DOTA-Tyr(^3)-
octreotide [DOTATOC]) reduces scan time, enhances spatial resolution, detects more 
lesions [5]. Different 68Ga-DOTA-SSTR tracers exhibit subtype-specific affinity: 
68Ga-DOTATATE targets SSTR2; 68Ga-DOTA-NOC prefers SSTR3/SSTR5; 68Ga-
DOTATOC has lower SSTR5 affinity [6]. Recent studies [7–11] confirm 68Ga-
DOTA-SSTR PET/CT’s high diagnostic value for localizing primaries, guiding 
clinical strategy, detecting occult metastases, and improving staging/prognosis. Thus, 
Nordic/U.S. guidelines endorse SSTR PET/CT for NEN diagnosis. 
18F (97% β(+), T({1/2})=109.7 min) is ideal for peptide-based PET imaging due to 
favorable physicochemical properties [12]. 18F-FDG, the most common PET tracer, is 
preferred for aggressive/poorly differentiated NEN but lacks sensitivity/specificity for 
indolent/well-differentiated cases [13–14]. Compared to 68Ga tracers, 18F-labeled 
SSTR offers superior resolution potential, making it clinically valuable. 
18F-AlF-NOTA-octreotide 18F-Octreotide) enables rapid peptide synthesis, 
accumulates markedly in NEN, and exhibits excellent safety/dosimetry. Versus 18F-
FDG, 18F-Octreotide provides better tumor-to-background contrast in well-
differentiated NEN imaging [15]. 
2. Research Objectives and Content 
2.1 Objectives 

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This study utilizes 18F-Octreotide PET/CT or PET-MR in suspected/confirmed NEN 
patients to evaluate diagnostic efficacy (via postoperative pathology), therapeutic 
response, and prognosis prediction. It aims to clarify the role of 18F-Octreotide 
imaging in tumor localization, treatment planning, prognosis, and peptide receptor 
radionuclide therapy (PRRT) selection. The technique also holds promise for lesion 
segmentation, grading, survival prediction, and genotyping. 
2.2 Research Content 
(1) Primary diagnosis cohort: Multimodal imaging 18F-Octreotide PET/CT or PET-
MR + contrast-enhanced CT/MR) followed by biopsy/surgical pathology (gold 
standard, including grading, Ki-67, SSTR2, TP53/Rb status). 
(a) Diagnostic efficacy: Calculate sensitivity, specificity, NPV, PPV, AUC-ROC; 
assess concordance between imaging and pathology. 
(b) TNM staging: Compare lesion detection rates of 18F-Octreotide imaging vs. 
CT/MR; evaluate staging accuracy. 
(c) Tumor heterogeneity: Quantify intratumoral heterogeneity via 18F-Octreotide 
PET; develop quantitative methods and compare with radiomics for predicting 
pathological complete response (pCR). 
(2) Recurrence cohort: Post-treatment (surgery/endocrine therapy/chemotherapy) 
multimodal imaging. 
Assess response per PERCIST criteria, explore dynamic imaging parameters for 
recurrence risk prediction. 
Combine radiomics/AI to identify prognostic parameters. 
3. Tracer Characteristics, Mechanism, and Scope 
3.2 Tracer Characteristics 

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Quality control per Chinese Pharmacopoeia (2015 edition), Radiopharmaceutical 
Testing: 
Appearance: Colorless, transparent, sterile, pyrogen-free aqueous/ethanol (15%) 
solution. 
pH: Within specified range (tested via pH strip/meter). 
Specific activity: ≥37 × 10(^3) MBq/mol (measured by activimeter). 
Radionuclide purity: γ-spectrometry shows only 0.511 MeV and 1.02 MeV peaks. 
Radiochemical purity: ≥95% (TLC/HPLC). 
Chemical purity: ≥95% (HPLC). 
Microbiology: Sterile, apyrogenic. 
Endotoxin: Below threshold. 
Acetonitrile: ≤0.01% 
K222: ≤50 ng/mL. 
3.3 Mechanism and Scope 
18F’s properties make it ideal for peptide-based PET [12]. While 18F-FDG suits 
aggressive NEN, it underperforms in indolent cases [13–14]. 18F-labeled SSTR 
tracers offer higher resolution than })Ga analogs, promising broad clinical utility. 
4. Indications, Contraindications, and Precautions 
4.1 Indications: Suspected or confirmed NEN patients. 
4.2 Contraindications: 
Inability to undergo biopsy/surgery. 
Active malignancy or history within 5 years. 

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Severe uncontrolled comorbidities/active infections. 
Inability to provide informed consent. 
4.3 Precautions: 
Pregnant/lactating women require medical guidance and signed consent. 
5. Overall Design 
5.1 Research Methodology 
This prospective, single-center, cross-sectional study evaluates the diagnostic efficacy 
of 18F-Octreotide PET/CT in patients with neuroendocrine neoplasms (NEN). A total 
of 152 subjects will be enrolled from the First Affiliated Hospital, Zhejiang University 
School of Medicine. 
5.2 Bias Minimization Measures 
5.2.1 Blinding: Not applicable (open-label). 
5.2.2 Clinical Endpoint Determination: Biopsy or surgical pathology serves as the gold 
standard. 
5.3 Subject Selection 
5.3.1 Inclusion Criteria: 
(1) Clinical diagnosed of NENs. 
(2) Suspected of NENs. 
5.3.2 Exclusion Criteria: 
(1) Inability to undergo biopsy/surgical treatment. 
(2) Concurrent active malignancy. 
(3) Severe uncontrolled comorbidities/active infections. 

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(4) Inability to provide informed consent. 
5.3.3 Criteria and Procedures for Subject Withdrawal: 
Subjects not meeting inclusion criteria (verified via medical history/electronic records) 
will be excluded. Subjects may withdraw during the procedure due to hypoglycemia, 
tremor, pain, or severe abdominal discomfort. 
5.3.4 Loss to Follow-up: 
• Defined as incomplete follow-up without formal withdrawal. 
• For subjects receiving biopsy/surgery elsewhere, ≥3 phone attempts will be made. 
Unresponsive cases after 3 calls + certified mail will be deemed "lost to follow-up." 
• Lost subjects are excluded from diagnostic efficacy analysis but included in safety 
assessment if data are available. 
5.3.5 Enrollment Period: December 2024 to December 2027 (3 years). 
5.3.6 Sample Size: 152 cases. 
5.4 Study Endpoints: 
Study completion is defined as completion of multimodal imaging and acquisition of 
pathological results. 
________________________________________ 
6. Research Procedures and Protocols 
6.1 Ethics and Informed Consent 
• The study commences after ethics committee (EC) approval. Protocol amendments 
require re-approval. 
• EC approval (including consent forms) must be documented with version/date. 

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• Written informed consent is mandatory before enrollment. 
6.2 Subject Screening 
• Consent is obtained after explaining risks/benefits. Subjects receive time to consider 
participation. 
• Baseline data (general exams, labs, history from within 1 week pre-consent) are 
collected. Adverse events/concomitant medications are recorded post-consent. 
6.3 Medical History Collection 
Comprehensive documentation of: 
• Symptoms, signs, and history (tumors, surgeries, biopsies, radiotherapy, 
chemotherapy, allergies, octreotide/PRRT history). 
• Lab tests: Fasting insulin, CgA, proinsulin/C-peptide, NSE, VIP, Syn, VMAT-2, 
CD56. 
• Prior imaging (X-ray, US, CT, MRI, 18F-FDG PET/CT/MR). 
• Recent pathology (grading, Ki-67 index). 
6.4 Patient Preparation 
Pregnancy: Avoid unless benefits outweigh risks. 
Hydration: Encourage water intake pre/post-injection to reduce radiation exposure and 
improve image quality. Void bladder pre-scan; catheterize if incontinence occurs. 
IV Access: Use a cannula to prevent tracer extravasation. 
Fasting/Fasting Medications: Not required. Withhold short-acting octreotide ≥24h and 
long-acting analogs 3–4 weeks pre-scan if feasible (evidence inconclusive). 
6.5 Radiopharmaceutical Administration 

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• Dose: 18F-Octreotide (3.7 MBq/kg, range 3.7–4.44 MBq; obese patients may receive 
higher doses). 
• Administration: IV injection separate from parenteral nutrition lines. 
6.6 Image Acquisition 
• Patient Positioning: Arms at sides for whole-body scans; arms raised for 
chest/abdomen. 
• CT Protocol: For attenuation correction/anatomic localization. Use low-dose 
principles where feasible. 
• PET Protocol: 
Optimal imaging: 45–60 min post-injection. 
Scan range: Skull base to mid-thigh (adjust per clinical needs). 
Acquisition time varies by dose, BMI, scanner. 
• Interventions: Hydration ± diuretics/catheterization to reduce urinary tracer activity. 
• Reconstruction: Iterative reconstruction + time-of-flight (if available); parameters 
optimized per patient/scanner. 
6.7 Image Interpretation 
• Normal Biodistribution: Spleen (highest), kidneys, liver, adrenals, pituitary, salivary 
glands. Minimal uptake in brain/lungs/muscle; excreted via kidneys. 
• Pathologic Uptake: Focal uptake in non-physiologic sites (vs. diffuse bowel uptake = 
non-pathologic). 
• Malignancy Criteria: Uptake > liver = SSTR-positive malignancy. Correlates with 
tumor grade/SSTR expression. 
6.8 Reporting Standards 

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Objectives: Address referring physicians’ clinical queries and justify 
necessity/diagnostic value of })-Octreotide imaging. 
Procedure Flow: 
Registration → 2. Preparation (fast ≥4h) → 3. History/consent → 4. 18F-Octreotide 
injection → 5. Uptake period (60 min) → 6. Scan (20–30 min). 
7 Statistical Considerations 
7.1 Total Sample Size 
Assuming a sensitivity of 0.90, specificity of 0.88, and disease prevalence of 0.25 
from literature, with a margin of error of 0.1 and α = 0.05: 
For sensitivity calculation: 
( N_1 = \frac{1.96^2 \times 0.9 \times (1-0.9)}{0.1^2 \times 0.25} = 138 ) 
For specificity calculation: 
( N_2 = \frac{1.96^2 \times 0.88 \times (1-0.88)}{0.1^2 \times (1-0.25)} = 54 ) 
The theoretical sample size is estimated at 138 cases. Accounting for a 10% expected 
dropout rate (based on prior studies), the adjusted total sample size is 152 cases. 
7.2 Significance Level and Power 
Significance level: α = 0.05 
Power: 0.95 
7.3 Statistical Methods 
Analysis performed using SPSS 17.0: 
Sensitivity, specificity, and positive/negative predictive values calculated via 2×2 
contingency tables. 

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ROC curves used to determine AUC and optimal cut-off values (e.g., SUV 
thresholds). 
Kappa test evaluated consistency between 18F-Octreotide PET/CT and pathological 
diagnoses. 
Statistical significance: p < 0.05. 
________________________________________ 
8 Data Recording and Management 
8.1 Investigator Data Recording 
Detailed records of all eligible subjects, including laboratory results. 
Two nuclear medicine physicians (≥5 years’ experience) independently interpret 
imaging; discrepancies resolved by a senior consultant. 
Original data signed and dated by the investigator. 
All adverse events (AEs) documented; serious adverse events (SAEs) reported per 
protocol. 
________________________________________ 
9 Expected Timeline 
Recruitment period: 36 months 
Follow-up: Ends upon completion of 18F-Octreotide PET/CT and pathological 
confirmation. 
________________________________________ 
10 Adverse Event Assessment and Reporting 
10.1 Definition 

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Any untoward medical occurrence related to imaging/radiopharmaceuticals 
during/after the study, including symptoms, signs, or lab abnormalities. 
10.2 Major Adverse Events 
PET/CT risks: Potential radiation exposure. 
18F-Octreotide risks: Rare mild reactions (rash, pruritus); severe reactions (shock) not 
reported in literature. 
10.3 Documentation of AEs 
Use standardized medical terminology. 
Include: 
Start/end dates 
Severity 
Causality assessment 
Action taken 
Outcome 
10.4 Reporting of SAEs 
Immediate actions taken. 
Written reports submitted within 24 hours to: 
Institutional Ethics Committee 
Provincial regulatory authorities 
Contact: 
Affiliated Hospital 1, Zhejiang University School of Medicine 

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Su Xinhui: 13806071262 
Chen Donghe: 13777452235 
10.5 AE Follow-up 
All AEs followed until resolution. 
________________________________________ 
11 Quality Control (QC) & Assurance (QA) 
11.1 Laboratory QC 
18F-Octreotide prepared per Chinese Pharmacopoeia 2015. 
Batch testing: pH, specific activity, radiochemical/radionuclide purity, endotoxin, 
sterility. 
Reports signed and dated. 
11.2–11.4 Staff & Procedures 
Investigators: Certified, GCP-trained, and experienced. 
Pre-study training on protocols. 
QA ensures compliance with Good Practice for Radioactive Pharmaceuticals. 
________________________________________ 
12–14 Data Confidentiality & Storage 
Confidentiality: Subject identities protected; data anonymized (ID codes only). 
Storage: Original records retained for 10 years post-study. 
________________________________________ 
15 Study Termination & Reporting 

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Summary report prepared by lead unit and submitted to regulatory authorities. 
Results may be published or used for regulatory submissions. 
________________________________________ 
16–18 Responsibilities 
Sponsors: 
Training, protocol adherence, data auditing. 
Investigators/Sites: 
Obtain informed consent. 
Report AEs/SAEs within 24 hours. 
Protect subject safety; halt study if necessary. 
Maintain certification and site facilities (e.g., radioprotection, waste management). 
Pre-study training on radiopharmaceutical handling/imaging protocols. 
Refrences：  
[1].Barakat MT, Meeran K, Bloom SR．Neuroendocrine tumours．Endocr Relat 
Cancer, 2004, 11(1): 1-18． 
[2]. Dasari A, Shen C, Halperin D, et al. Trends in the incidence, prevalence, and 
survival outcomes in patients with neuroendocrine tumors in the United States. JAMA 
Oncol.2017, 3: 1335-1342. 
[3]. BozkurtMF, Virgolini I, Balogova S, et al. Guideline for PET/CT imaging of 
neuroendocrine neoplasms with (68) Ga-DOTA–conjugated somatostatin receptor 
targeting peptides and (18)F-DOPA.Eur J Nucl Med Mol Imaging.2017; 44:1588–
1601. 

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[4]. Kwekkeboom DJ, Kooij PP, BakkerWH, et al. Comparison of 111In-DOTATyr3-
octreotide and 111In-DTPA-octreotide in the same patients: biodistribution, kinetics, 
organ and tumor uptake. J Nucl Med.1999; 40: 762–767. 
[5]. Sadowski SM, Neychev V, Millo C, et al. Prospective study of 68Ga-
DOTATATE positron emission tomography/computed tomography fordetecting 
gastro-entero-pancreatic neuroendocrine tumors and unknown primary sites.J Clin 
Oncol.2016; 34: 588–596. 
[6]. Putzer D，Kroiss A，Waitz D，et a1．Somatostatin receptor PET in 
neuroendocrine tumours：68 Ga-DOTA-Tyr3-octreotide versus” Ga-
DOTAolanreotide．Eur J Nucl Med Mol Imaging．2013; 40 (3): 364-372． 
[7]. Yamaga LYI, Cunha ML, Campos Neto GC, et a1. 68Ga DOTATATE PET/CT in 
recurrent medullary thyroid carcinoma: A lesion-by-lesion comparison with“1 In-
octreotide SPECT/CT and conventional imaging. Eur J Nucl Med Mol Imaging，
2017,44 (10)：1695-1701． 
[8]. Sadowski SM．Millo C，Cottle-Delisle C，et a1．Results of 68Gallium-
DOTATATE PET/CT scanning in patients with multiple endocrine neoplasia type 1. J 
Am Coil Surg，2015，221 (2)：509-517． 
[9].Bodei L, Ambrosini V, Herrmann K, et al Current concepts in 68 Ga-DOTATATE 
imaging of neuroendocrine neoplasms: Interpretation, Biodistribution, Dosimetry, and 
Molecular Strategies.J Nucl Med. 2017 Nov; 58(11):1718-1726.  
[10] Barrio M, Czernin J, Fanti S, et a1. The impact of somatostatin receptor-directed 
PET/CT on the management of patients with neuroendocrine tumor: A systematic 
review and Meta-snalysis. J Nucl Med, 2017, 58(5): 756-761． 
[11]. Conry BG, Papathanasiou ND, Prakash V, Kayani I, Caplin M, Mahmood S, 
Bomanji JB. Comparison of (68) Ga-DOTATATE and (18)F-fluorodeoxyglucose 

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PET/CT in the detection of recurrent medullary thyroid carcinoma.Eur J Nucl Med 
Mol Imaging. 2010 Jan;37(1):49-57． 
[12]. Coenen HH, Elsinga PH, Iwata R, et al. Fluorine-18 radiopharmaceuticals 
beyond [18F]FDG for use in oncology and neurosciences.Nucl Med Biol. 2010; 
37:727–740. 
[13]. Kayani I, Bomanji JB, Groves A, et al. Functional imaging of neuroendocrine 
tumors with combined PET/CT using 68Ga-DOTATATE (DOTADPhe1, Tyr3-
octreotate) and 18F-FDG.Cancer.2008; 112: 2447–2455. 
[14]. Krenning EP, Valkema R, Kwekkeboom DJ, et al. Molecular imaging as in 
vivomolecular pathology for gastroenteropancreatic neuroendocrine tumors: 
implications for follow-up after therapy. J Nucl Med. 2005; 46(Suppl 1): 76S–82S. 
[15]. Long T, Yang N, Zhou M, Chen D, Li Y, Li J, Tang Y, Liu Z, Li Z, Hu S. 
Clinical Application of 18F-AlF-NOTA-Octreotide PET/CT in Combination With 
18F-FDG PET/CT for Imaging Neuroendocrine Neoplasms. Clin Nucl Med. 2019 Jun; 
44 (6):452-458. 
[16]. Virgolini I, Ambrosini V, Bomanji JB, Baum RP, Fanti S, Gabriel M, 
Papathanasiou ND, Pepe G, Oyen W, De Cristoforo C, Chiti A. Procedure guidelines 
for PET/CT tumour imaging with 68Ga-DOTA-conjugated peptides: 68Ga-DOTA-
TOC, 68Ga-DOTA-NOC, 68Ga-DOTA-TATE.Eur J Nucl Med Mol Imaging. 2010 
Oct; 37 (10):2004-10. 
 
 
 
 

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Informed Consent Form for Clinical Research Project 
Protocol Title: Prospective study of 18F-AlF-NOTA-Octreotide PET-CT or PET-
MR in diagnosis, treatment and prognosis for Neuroendocrine Neoplasms 
Protocol Number: 
Protocol Version: 2.0 (November 16, 2024) 
Informed Consent Version: 2.0 (November 16, 2024) 
Research Institution: First Affiliated Hospital, Zhejiang University School of 
Medicine 
Principal Investigator: Chen Donghe 
Subject Name: 
Subject Initials: 
Subject Address: 
Subject Phone: 
We invite you to participate in this clinical research. This informed consent form 
provides information to help you decide whether to join. Please take time to read it 
carefully. If you have questions or need clarification, discuss them with the study 
physician. 
Participation is completely voluntary. This study has been reviewed and approved by 
the Hospital Clinical Research Ethics Committee—IIT Ethics Review Panel. 
Background 
Neuroendocrine neoplasms (NEN) are heterogeneous tumors arising from 
neuroendocrine cells distributed throughout the body. Common sites include the 
gastrointestinal tract, pancreas, and lungs. Symptoms may relate to hormone secretion 

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and vasoactive peptides entering circulation. Over the past decade, NEN incidence and 
prevalence have increased. Precision oncology emphasizes genetic testing and targeted 
therapies, yet NEN lacks precise biomarkers for prognosis or treatment selection. 
Current imaging (ultrasound, CT, MRI) struggles to accurately diagnose or assess 
NEN. Thus, a highly sensitive diagnostic tool is urgently needed. Nuclear medicine, 
particularly somatostatin receptor (SSTR) imaging, plays a key role. As most NENs 
express SSTR, SSTR analogs serve as targets for radionuclide imaging. The FDA-
approved ⁶⁸Ga-DOTA-SSTR PET/CT outperforms traditional methods by reducing 
scan time and improving lesion detection. However, ¹⁸F-labeled SSTR tracers (e.g., 
¹⁸F-Octreotide) offer superior resolution and tumor-to-background ratios. 
Research Objectives 
This study uses ¹⁸F-Octreotide PET-CT/PET-MR to: 
1. 
Evaluate diagnostic accuracy (sensitivity, specificity, NPV, PPV, AUC) using 
pathology (Ki-67, SSTR2, P53, Rb) as the gold standard. 
2. 
Assess TNM staging accuracy and lesion detection rates compared to contrast 
CT/MRI. 
3. 
Quantify tumor heterogeneity via radiomics/AI, predicting postoperative pCR 
and recurrence risk. 
4. 
Explore dynamic imaging parameters (PERCIST criteria) for prognosis and 
peptide receptor radionuclide therapy (PRRT) efficacy prediction. 
Study Procedures 
• 
Newly Diagnosed Patients: Multimodal imaging (¹⁸F-Octreotide PET-CT/PET-
MR + contrast CT/MRI), followed by pathology. 
• 
Recurrent Patients: Post-treatment multimodal imaging for efficacy assessment. 

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Risks and Discomforts 
• 
Radiation: Minimal risk from PET-CT; procedures comply with Radiation 
Protection Requirements for X-ray Computed Tomography. 
• 
Tracer: ¹⁸F-Octreotide may cause mild reactions (rash, pruritus); severe 
reactions (e.g., shock) are rare. Emergency SOPs are in place. 
Potential Benefits 
You may benefit from precise tumor localization. Results may advance care for future 
patients with similar conditions. 
Costs and Compensation 
• 
¹⁸F-Octreotide is provided without charge. PET-CT scan fees are self-paid. 
• 
No financial compensation. 
Privacy and Confidentiality 
Your identity will be coded and protected. Study data may be published anonymously. 
Regulatory authorities may review records for quality assurance. 
Contact Information 
For questions, contact: 
• 
Dr. Chen Donghe or Su Xinhui: 87236432 
• 
Ethics Committee: 0571-87233418, 79 Qingchun Road, Hangzhou 
________________________________________ 
 
 

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Consent Statement 
I confirm that: 
1. 
I understand this research, its risks, and have had my questions answered. 
2. 
Participation is voluntary; refusal will not affect my medical care. 
3. 
I permit access to my records by study staff, the institution, and ethics 
committees under confidentiality safeguards. 
4. 
I agree to participate. 
Subject Signature: ________________ Date: _____________ 
Subject Contact: ________________ 
If subject lacks capacity: 
Guardian Signature: ________________ Date: _____________ 
Guardian Contact: ________________ Relationship: ____________ 
If subject cannot read this form: 
Witness Signature: ________________ Date: _____________ 
Witness Contact: ________________ 
Investigator Signature: ________________ Date: _____________ 
Investigator Contact: ________________