Clinical Trial Finder

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 or MRI obtained within 6 months of enrolment is required. 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.

The proposed clinical trial will be a sequential Phase I/II, diagnostic imaging, controlled, open label, single site study in a broad cross-section of patients with known or suspected somatostatin receptor positive tumours. All participants will be imaged with [68]Ga-HA-DOTATATE PET/CT or PET/MRI for uptake by somatostatin receptor positive tumours. Up to seven [68]Ga-HA-DOTATATE scans may be performed per participant, as clinically indicated. A safety evaluation will be conducted on the first 10 consecutively enrolled participants (safety sub-group), consisting of vital signs, haematology and serum biochemistry profile (pre-injection and post-imaging), and an adverse event (AE) assessment (up to 24 hours) after [68]Ga-HA-DOTATATE imaging. The safety evaluation for subsequent [68]Ga-HA-DOTATATE scan visits for participants in the safety sub-group and for the remaining participants will consist of an AE assessment while in the Nuclear Medicine department. The efficacy evaluation will include [68]Ga-HA-DOTATATE scan clinical accuracy compared to standard of care CT or MRI.

Arms

Experimental: [68]Ga-HA-DOTATATE

All participants will be imaged with [68]Ga-HA-DOTATATE PET/CT or PET/MRI for uptake by somatostatin receptor positive tumours. Up to seven [68]Ga-HA-DOTATATE scans may be performed per participant, as clinically indicated.

Interventions

Drug: - [68]Ga-HA-DOTATATE

All participants will be injected with [68]Ga-HA-DOTATATE approximately 60 minutes before PET/CT or PET/MRI scan.