Clinical trial NCT03136328: Diagnosis and Staging of Neuroendocrine Tumors (NETs) Utilizing 68Ga-DOTATOC PET/CT Scan
Official title: Diagnosis and Staging of Neuroendocrine Tumors (NETs) Utilizing 68Ga-DOTATOC PET/CT Scan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neuroendocrine Tumors
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: NCM USA
First posted: 2017-05-02
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary goal of the analysis is to estimate the diagnostic accuracy of Gallium 68 (68Ga) -DOTATOC PET/CT for detecting neuroendocrine tumors (NETs) compared to conventional imaging techniques such as Magnetic Resonance Imaging (MRI) and Computerized Tomography (CT). Participants with histologically and/or clinically confirmed and/or suspected NET will be enrolled.

Detailed description: This is a prospective, Phase 2, single center study of participants with Neuroendocrine Tumors (NETs). Study participants will receive 68Ga-DOTATOC. DOTATOC is a somatostatin analogue that localizes on the somatostatin receptors expressed by NETs and is attached to a radioactive material called Gallium 68. Participants will undergo a PET/CT imaging study to investigate 68Ga-DOTATOC's suitability as a positron emission tomography (PET) imaging agent for NETs. The radiation (imaging) dose will be 111-185 megabecquerel (MBq) (3 - 5 mCi) ± 25%. All doses after labeling will be presented in buffered solution for intravenous injection. Imaging will start 90 ±30 minutes after injection.

Sensitivity and specificity of this imaging technique will be compared with those of conventional imaging modality including CT, MRI and In-111 Octreoscan performed within 6-12 months before or after PET/CT.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent.
* Patients of either gender, aged ≥18 years.
* Karnofsky status ≥60.
* Life expectancy of at least 12 weeks.
* Histologically and/or clinically confirmed and/or suspicious of NET.
* A diagnostic CT or MRI of the tumour region or suspected area within the previous 12 weeks prior to dosing day is available.
* Somatostatin-analogue scintigraphy scan with result (positive or negative) within the last 12 weeks.
* Recent Blood test results up to 4-6 weeks as follows:

  1. White Blood Cell (WBC): \>2\*109/L
  2. Haemoglobin: \>8.0g/Dl
  3. Platelets: \>50x109/L
  4. Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Alkaline phosphatase (AP) each less than, or equal to, 5 times its Upper Limit of Normal (ULN)
  5. Bilirubin less than, or equal to, three times its ULN
* Serum creatinine: within normal range or \<120μmol/L for patients aged 60 years or older.
* Negative pregnancy test in women capable of child-bearing.

Exclusion Criteria:

* Known hypersensitivity to Gallium 68, DOTATOC or to any of the excipients of 68Ga-DOTATOC.
* Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (Long Acting Release) (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a patient is on Sandostatin® LAR a wash-out phase of 28 days is required before the injection of the study drug.
* Pregnant or breast-feeding women.
* Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.

Primary outcomes:
measure: Sensitivity to Correctly Diagnose NET
timeFrame: During imaging process ( approximately 120 minutes)
Secondary outcomes:
measure: Specificity to Detect True Negative
timeFrame: During imaging process ( approximately 120 minutes)
Other outcomes:
Locations:
Study officials:
affiliation: Montefiore Medical Center
name: Charito Love, MD
role: PRINCIPAL_INVESTIGATOR
References: