New method to identify and diagnose tumors with somatostatin receptors
A Phase I/II Study of Gallium-68 HA-DOTATATE ([68]Ga-HA-DOTATATE) in Patients With Known or Suspected Somatostatin Receptor Positive Tumours
This study is testing a new imaging agent to see if it can better detect certain tumors, especially neuroendocrine tumors, compared to the current standard method.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 1534 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | AHS Cancer Control Alberta Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT03145857 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of a new imaging agent, [68]Ga-HA-DOTATATE, for detecting somatostatin receptor positive tumors, particularly neuroendocrine tumors (NETs). Participants will undergo PET/CT or PET/MRI scans to assess the uptake of this agent in their tumors. The study aims to demonstrate that [68]Ga-HA-DOTATATE is more accurate than the current standard imaging method, In-111 Octreotide scans. Safety evaluations will be conducted on the first 10 participants, while efficacy will be compared to standard imaging techniques.
Who should consider this trial
Good fit: Ideal candidates include individuals with known or suspected somatostatin receptor positive tumors such as neuroendocrine tumors, pheochromocytoma, or medullary thyroid cancer.
Not a fit: Patients without suspected somatostatin receptor positive tumors or those with an ECOG Performance Scale Score greater than 3 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses of neuroendocrine tumors, improving patient outcomes.
How similar studies have performed: Previous studies have shown that similar imaging agents, like [68]Ga-DOTATATE, have been more effective than traditional methods, suggesting a positive outlook for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Edmonton, Alberta
- Cross Cancer Institute — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Todd PW McMullen, MD, PhD, FRCSC, FACS — Associate Professor of Surgery and Oncology; Director, Division of Surgical Oncology, Department of Oncology
- Study coordinator: NET Coordinator
- Email: ACB.NeuroEndocrine@ahs.ca
- Phone: 780-577-8080
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.