Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||N/A and Over|
Inclusion Criteria:1. Clinical requisition for a 68Ga-DOTA-TATE PET/CT signed by a referring doctor. 2. Patients with suspected or proven tumors expressing somatostatin receptors. 3. Informed consent by patient (or parents if patient is less than 18 years of age)
Exclusion Criteria:1. *Pregnancy (not an absolute exclusion). See below*. 2. Patient refusal to participate. 3. Prior severe anaphylactic reaction to DOTA-TATE or somatostatin analogs.
- - In the case of a diagnostic procedure in a patient who is or may be pregnant, the principle of benefits-disadvantages would be applied following an in-depth discussion with the treating physicians and the patient.
- - Severe medical condition involving the life of the pregnant woman and/or the fetus; - Existing treatments that are ineffective or may present toxicity to the woman and/or fetus; - High clinical suspicion of a somatostatin receptor overexpressing tumour; - Negative, indeterminate or contraindicated first-line imaging tests; - Therapeutic gesture considered during pregnancy based on the results of the examination, which may include termination of pregnancy or premature delivery; - Documented discussion with the treating team and the patient; - Patient agrees.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Centre de recherche du Centre hospitalier universitaire de Sherbrooke|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Éric E Turcotte, MD|
|Principal Investigator Affiliation||Centre de recherche du Centre hospitalier universitaire de Sherbrooke|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: Neuroendocrine cancer patients
All neuroendocrine cancer patients referred by their physician and fulfilling the eligibility criteria across Canada can be recruited to the primary site of the study. Patients will be injected intravenously with 3 MBq/kg (maximum 370 MBq) of 68Ga-DOTA-TATE. 45-90 minutes following injection, patients will be imaged in a PET/CT scanner. Images will be analyzed by a trained nuclear medicine physician. Safety profile, eventual adverse effects, false positives, false negatives and any abnormal biodistribution of the radiotracer will be monitored and analysed.
Diagnostic Test: - 68Ga-DOTA-TATE
The intervention consists of an intravenous injection of the radiopharmaceutical 68Ga-DOTA-TATE and a physiological saline flush, followed 45-90 minutes later by a PET/CT image acquisition.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.