Clinical trial · Interventional
Al18F-NOTA-octreotide PET Imaging of the Somatostatin Receptor in Neuroendocrine Tumors
Al18F-NOTA-octreotide PET Imaging of the Somatostatin Receptor in Neuroendocrine Tumors: a First-in-human PET/CT Study
NCT03883776CI-TRIAL-00047029completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to evaluate the potential of Al18F-1,4,7-triazacyclononane-1,4,7-triacetate-octreotide (Al18F-NOTA-octreotide) as a positron emission tomography (PET) somatostatin receptor imaging agent in patients with neuroendocrine tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Al18F-NOTA-octreotide | Drug | — | UNRESOLVED |
| PET/CT | Device | — | UNRESOLVED |
| Venous blood samples | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- healthy volunteers and NET patients
- description
- In the first part of the study, 6 healthy volunteers will receive a single intravenous single injection of Al18F-NOTA-octreotide, followed by whole-body PET/CT scans at various time points for an initial safety assessment and dosimetry study. In the second part of the study, a single dose of Al18F-NOTA-octreotide will be intravenously injected in 6 patients with neuroendocrine tumors. Patients will first undergo a dynamic PET scan, followed by whole-body PET/CT scans at various time points for a pharmacokinetics study and initial efficacy assessment.
- interventionNames
- Drug: Al18F-NOTA-octreotide
- Device: PET/CT
- Other: Venous blood samples
Primary outcomes (1)
- measure
- Potential of Al18F-NOTA-octreotide as somatostatin receptor PET imaging tracer in patients with neuroendocrine tumors
- timeFrame
- 1 year
- description
- The primary endpoint will be met if in 4 out of 6 patients, at least two tumor lesions per patient are visualized in case of 5 to 10 known positive lesions on the 68Ga-DOTA-peptide PET, or at least 25% of the known tumor lesions per patient are visualized in case of more than 10 known positive tumor lesions on the 68Ga-DOTA-peptide PET. The study will be partially positive if in at least one patient at least 80% of the known positive lesions on the 68Ga-DOTA-peptide PET is visualized.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: Part 1: Healthy volunteers: * Age between 18 and 65 years * Signed Informed Consent * Subject is judged to be in good health by the investigator on the basis of medical history, physical examination including vital signs and clinical laboratory tests * Female subjects should be post-menopausal or surgically sterile or using effective contraceptive with negative urinary pregnancy test Part 2: Neuroendocrine tumor patients: * Age between 18 and 75 years * Signed Informed Consent * Subject is diagnosed with a neuroendocrine tumor of gastroenteropancreatic, pulmonary, neural crest or unknown primary origin * Subject is judged to be in good general condition by the investigator on the basis of medical history, physical examination including vital signs and clinical laboratory tests, besides the diagnosis of neuroendocrine tumor. * Subject should have at least 5 positive lesions on routine clinical 68Ga-DOTA-peptide PET performed within 6 months prior to the inclusion visit. A positive lesion is defined as tracer uptake above background deemed to be caused by the presence of NET cells by an experienced nuclear medicine physician * Female subjects should be post-menopausal or surgically sterile or using effective contraceptive with negative pregnancy test Exclusion Criteria: Part 1: Healthy volunteers: * Subject has a previous or ongoing recurrent or chronic disease able to interfere with the evaluation of the trial according to the judgement of the investigator, especially a known gastro-intestinal, hepatic, renal, cardiovascular, metabolic or hormonal disease, cancer, major neurological or convulsive disorder or any psychiatric disease * Subject is currently a user (including ''recreational use'') of any illicit drugs, including cannabis, or has a history of drug or alcohol abuse * Subject takes concomitant medication, except for oral contraceptives, sporadic paracetamol, or low-dose and limited in time non-steroidal antiinflammatory drugs * Subject is unable to refrain from smoking more than 10 cigarettes per day during the study * Subject has had exposure to ionizing radiation (\> 1 mSv) in other research studies within the last 12 months * Subject suffers from claustrophobia or cannot tolerate confinement during PET/CT scanning procedures; subject cannot lie still for 90 minutes inside the scanner * Subject is unwilling to avoid unusual, unaccustomed, or strenuous physical activity (i.e. weight lifting, running, bicycling) from the time of the selection visit until the safety visit * Subject does not understand the study procedure * Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator * Subject is potentially pregnant (urinary hCG test will be performed in women where pregnancy is not excluded), wishes to become pregnant up to 3 months after administration of Al18F-NOTA-octreotide or is breast-feeding * Subject has recently (\< 30 days) participated or is simultaneously participating in another prospective interventional clinical trial * Subject has a history of multiple and/or severe allergies to drugs or food * Subject underwent surgery between the selection and inclusion visit * Subject is mentally or legally incapacitated Part 2: Neuroendocrine tumor patients: * Subject has a previous or ongoing recurrent or chronic disease, other than a neuroendocrine tumor, at high risk to interfere with the evaluation of the trial according to the judgement of the investigator, e.g. known gastro-intestinal, hepatic, renal, cardiovascular, metabolic or hormonal disease, cancer, major neurological or convulsive disorder or any psychiatric disease * Subject is currently a user (including ''recreational use'') of any illicit drugs, including cannabis, or has a history of drug or alcohol abuse * Subject is unable to refrain from smoking more than 10 cigarettes per day during the study * Subject has had exposure to ionizing radiation (\> 1 mSv) in other research studies within the last 12 months * Subject suffers from claustrophobia or cannot tolerate confinement during PET/CT scanning procedures; subject cannot lie still for 60 minutes inside the scanner * Subject is unwilling to avoid unusual, unaccustomed, or strenuous physical activity (i.e. weight lifting, running, bicycling) from the time of the selection visit until the telephone follow-up interview. * Subject does not understand the study procedure * Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator * Subject is potentially pregnant (urinary hCG test will be performed in women where pregnancy is not excluded), wishes to become pregnant up to 3 months after administration of Al18F-NOTA-octreotide or is breast-feeding * Subject has recently (\< 30 days) participated or is simultaneously participating in another prospective interventional clinical trial * Subject has a history of multiple and/or severe allergies to drugs or food * Subject underwent surgery between the selection and inclusion visit * Subject is mentally or legally incapacitated
References
Publications (1)
- RESULTPauwels 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. PMID 32617641