Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-24 @ 7:00 PM
NCT ID:
NCT03145857
Eligibility Criteria:
Inclusion Criteria:
1. Known or suspected somatostatin receptor positive tumour including, but not limited to, GNET, PNET, pulmonary NET, PRUNK NET, pheochromocytoma, paraganglioma, medullary thyroid cancer, and medulloblastoma. A standard CT obtained within 6 months of enrolment is required. A standard MRI obtained within 6 months of enrolment is optional. Additional supporting evidence obtained within 12 months of enrolment may include: other standard imaging (In-111 octreotide (Octreoscan), \[18\]F-FDG PET, or \[18\]F-FDOPA PET); histopathology from surgery or biopsy; elevated biochemical markers (including Chromogranin A, 5-HIAA, insulin, vasoactive intestinal peptide (VIP), glucagon, gastrin, metanephrines, and/or others, as clinically indicated); and/or persistent carcinoid-like symptomology highly suspicious for the presence of NET even in absence of pathologic imaging findings by anatomic criteria;
2. Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 3 within 2 weeks of enrolment;
3. At least 14 years of age;
4. Able and willing to follow instructions and comply with the protocol;
5. Ability to provide written informed consent prior to participation in the study.
Exclusion Criteria:
1. Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.);
2. Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.);
3. Any additional medical condition, serious inter-current illness or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study performance or interpretation;
4. Weight exceeding the PET/CT or PET/MR scanner limit;
5. Pregnancy;
6. Allergic reaction to DOTATATE or somatostatin analogues.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT03145857
Study Brief:
Protocol Section:
NCT03145857