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Radiopharmaceutical
68Ga-DOTA-TATE Imaging for Neuroendocrine Cancer
Phase 3
Recruiting
Led By Éric E Turcotte, MD
Research Sponsored by Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with suspected or proven tumors expressing somatostatin receptors
Clinical requisition for a 68Ga-DOTA-TATE PET/CT signed by a referring doctor
Must not have
Patient refusal to participate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is to establish the safety of a new PET radiotracer, 68Ga-DOTA-TATE, for diagnosing neuro-endocrine cancer patients. The trial is prospective, open-label, and single-center with recruitment across Canada. There is no control group.
Who is the study for?
This trial is for patients across Canada with suspected or confirmed neuroendocrine tumors that express somatostatin receptors. They must have a doctor's referral for the PET/CT scan and give informed consent. It's not suitable for those who refuse to participate, are pregnant without careful consideration of risks, or have had severe allergic reactions to DOTA-TATE or similar drugs.
What is being tested?
The study tests the safety of 68Ga-DOTA-TATE PET/CT imaging as a routine diagnostic tool for neuroendocrine cancer patients. This single-center, non-randomized trial seeks to establish this method over Octreoscan based on prior evidence supporting its superiority.
What are the potential side effects?
While specific side effects aren't listed in the provided information, potential side effects may include allergic reactions like anaphylaxis due to previous data suggesting such risks with DOTA-TATE or related medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor is suspected to or does express somatostatin receptors.
Select...
My doctor has requested a specific PET/CT scan for me.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not want to participate in the clinical trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety profile of 68Ga-DOTA-TATE
Secondary study objectives
Generate clinical information on the impact of 68Ga-DOTA-TATE for NET patient management
Instigate the routine standard-of-care use of 68Ga-DOTA-TATE for NET patients
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Neuroendocrine cancer patientsExperimental Treatment1 Intervention
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.
Find a Location
Who is running the clinical trial?
Jewish General HospitalOTHER
141 Previous Clinical Trials
273,619 Total Patients Enrolled
1 Trials studying Neuroendocrine Tumors
45 Patients Enrolled for Neuroendocrine Tumors
Centre de recherche du Centre hospitalier universitaire de SherbrookeLead Sponsor
61 Previous Clinical Trials
28,514 Total Patients Enrolled
1 Trials studying Neuroendocrine Tumors
2,120 Patients Enrolled for Neuroendocrine Tumors
Université de SherbrookeOTHER
305 Previous Clinical Trials
71,929 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My tumor is suspected to or does express somatostatin receptors.My doctor has requested a specific PET/CT scan for me.I do not want to participate in the clinical trial.I am pregnant and have a life-threatening condition that may require diagnostic procedures.You had a serious allergic reaction in the past to DOTA-TATE or similar medications.
Research Study Groups:
This trial has the following groups:- Group 1: Neuroendocrine cancer patients
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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