Clinical trial NCT04552847: Al18F-NOTA-octreotide PET Imaging in Neuroendocrine Tumors
Official title: Al18F-NOTA-octreotide PET Imaging of the Somatostatin Receptor in Neuroendocrine Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Neuroendocrine Tumors
Keywords: Somatostatin receptor imaging
Al18F-NOTA-octreotide
PET/CT
PET/MR
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: University Hospital, Antwerp
name: University Hospital, Ghent
name: NETwerk, Belgium
First posted: 2020-09-17
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to evaluate the diagnostic performance of Al18F-NOTA-octreotide PET imaging in comparison with the current golden standard, 68Ga-DOTA-somatostatin analog PET, in neuroendocrine tumor patients.

Detailed description: Part A (main part of the trial):

Seventy-five neuroendocrine tumor (NET) patients (M/F, aged 18 years and older) with a routine clinical 68Ga-DOTA-somatostin analog (SSA) PET/CT performed in the last three months or scheduled within three months, will undergo a whole-body Al18F-NOTA-octreotide PET/CT.

Part B:

At least 10, possibly up to 20 NET patients (M/F, aged 18 years and older) with a routine clinical 68Ga-DOTA-SSA PET/CT performed in the last three months or scheduled within three months, will undergo a whole-body Al18F-NOTA-octreotide PET/MR.

Eligibility criteria: Inclusion Criteria:

* Subject is aged over 18 years.
* Signed Informed Consent.
* Subject is diagnosed with a histologically and/or cytologically confirmed neuroendocrine tumor of all grades of gastroenteropancreatic, pulmonary, neural crest or unknown primary origin.
* Subject should have at least one known tumoral lesion below the level of the submandibular and parotid glands with either a minimum size of 1 cm in at least one dimension on morphological imaging (CT, MRI, ultrasound), or a maximal standardized uptake value (SUVmax) of at least 10 on 68Ga-DOTA-SSA PET, in both cases performed within 4 months prior to study scan. A positive lesion is defined as a volume of increased tracer uptake compared to background, deemed to be caused by the presence of NET cells, and that is unlikely to be attributed to physiological or benign etiology (e.g. inflammation, blood pool retention, excretion, etc.).
* Subject should have a routine clinical 68Ga-DOTA-SSA PET/CT performed within three months prior to the study scan or scheduled within three months after the study scan.
* Female subjects should be (a) post-menopausal, or (b) surgically sterile, or (c) using effective contraceptive with negative pregnancy test.

Exclusion Criteria:

Part A and B:

* Subject has a previous or ongoing recurrent or chronic disease, other than a neuroendocrine tumor, at high risk to interfere with the performance or evaluation of the trial according to the judgement of the investigator.
* Subject has had exposure to ionizing radiation (\> 1 mSv) in other research studies within the last 12 months.
* Subject has recently (\< 30 days or 5 times the plasma half-life of the investigated drug, whichever is longest) participated or is simultaneously participating in another prospective interventional clinical trial.
* Subject is unwilling to avoid unusual, unaccustomed, or strenuous physical activity (i.e. weight lifting, running, bicycling) beginning 4 days prior to tracer injection up to 1 day after tracer injection.
* Subject is potentially pregnant (urinary hCG test can be performed in case of doubt) or is breast-feeding.
* Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator.
* Subject does not understand the study procedure.
* Subject is mentally or legally incapacitated.

Only for part B:

* Subject has a contra-indication for MR scanning.
* Subject suffers from claustrophobia or cannot tolerate confinement during PET/MR scanning.
* Subject has an impaired renal function: estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m² (the last known value may not date from more than 3 months prior to the study PET/MR; if not available a blood analysis may be performed as part of the trial).
* Subject suffers from diseases for which butylhyoscine bromide (Buscopan®) is contra-indicated: glaucoma, paralytic ileus, severe colitis ulcerosa or myasthenia gravis.

Primary outcomes:
measure: Differential detection ratio (DDR)
timeFrame: 2 years
Secondary outcomes:
measure: Lesion detection rate on the organ level
timeFrame: 2 years
measure: Lesion uptake
timeFrame: 2 years
measure: Clinical impact on TNM staging or patient management
timeFrame: 2.5 years
measure: Lesion detection rate according to the specific 68Ga-DOTA-SSA used for the routine PET scan
timeFrame: 2 years
measure: Lesion detection rate according to tumor grade
timeFrame: 2 years
measure: Overall diagnostic image quality according to a five-point Likert-scale
timeFrame: 3 years
measure: Lesion conspicuity according to a five-point Likert-scale
timeFrame: 3 years
measure: Diagnostic confidence according to a five-point Likert-scale
timeFrame: 3 years
measure: Whole-body MRI correlate of the lesions detected by the PET scans
timeFrame: 2.5 years
measure: Effect of Al18F-NOTA-octreotide injection on blood pressure
timeFrame: 2 years
measure: Effect of Al18F-NOTA-octreotide injection on heart rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Christophe Deroose, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pauwels E, Cleeren F, Tshibangu T, Koole M, Serdons K, Dekervel J, Van Cutsem E, Verslype C, Van Laere K, Bormans G, Deroose CM. [18F]AlF-NOTA-octreotide PET imaging: biodistribution, dosimetry and first comparison with [68Ga]Ga-DOTATATE in neuroendocrine tumour patients. Eur J Nucl Med Mol Imaging. 2020 Dec;47(13):3033-3046. doi: 10.1007/s00259-020-04918-4. Epub 2020 Jul 2.
citation: Pauwels E, Cleeren F, Tshibangu T, Koole M, Serdons K, Boeckxstaens L, Dekervel J, Vandamme T, Lybaert W, den Broeck BV, Laenen A, Clement PM, Geboes K, Cutsem EV, Stroobants S, Verslype C, Bormans G, Deroose CM. 18F-AlF-NOTA-Octreotide Outperforms 68Ga-DOTATATE/NOC PET in Neuroendocrine Tumor Patients: Results from a Prospective, Multicenter Study. J Nucl Med. 2023 Apr;64(4):632-638. doi: 10.2967/jnumed.122.264563. Epub 2022 Oct 20.