A Study to Evaluate a New Way to Identify/Diagnose Tumours With Somatostatin Receptors Using [68]Ga-HA-DOTATATE and to Ensure it is Safe to Use

Launched by AHS CANCER CONTROL ALBERTA · May 8, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging test called \[68\]Ga-HA-DOTATATE, which is designed to help doctors find tumors that have somatostatin receptors. These receptors are often found on neuroendocrine tumors (NETs) and other types of tumors. The goal of the study is to ensure that this new imaging test is safe to use and to see if it works better than the current test, known as an Octreoscan™, in identifying these tumors.

To participate in the trial, you should be at least 14 years old and have a known or suspected somatostatin receptor positive tumor, such as certain types of NETs or medullary thyroid cancer. You’ll need to have had a standard CT or MRI scan within the past six months. If you decide to join, you can expect to undergo a PET/CT or PET/MRI scan, which will take pictures of your body to help detect any tumors. It's important to know that the study is open to all genders and that participants need to be able to lie still during the scan. If you have certain medical conditions, are pregnant, or have had allergic reactions to similar tests, you may not be eligible.

Gender

ALL

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.