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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

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My tumor is suspected to or does express somatostatin receptors.

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My doctor has requested a specific PET/CT scan for me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety profile of 68Ga-DOTA-TATE

Secondary outcome measures

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

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centre de recherche du Centre hospitalier universitaire de SherbrookeLead Sponsor

58 Previous Clinical Trials

26,165 Total Patients Enrolled

1 Trials studying Neuroendocrine Tumors

2,120 Patients Enrolled for Neuroendocrine Tumors

Université de SherbrookeOTHER

292 Previous Clinical Trials

64,441 Total Patients Enrolled

Éric E Turcotte, MDPrincipal InvestigatorCentre de recherche du Centre hospitalier universitaire de Sherbrooke

3 Previous Clinical Trials

3,500 Total Patients Enrolled

Media Library

68Ga-DOTA-TATE (Radiopharmaceutical) Clinical Trial Eligibility Overview. Trial Name: NCT04847505 — Phase 3

Neuroendocrine Tumors Research Study Groups: Neuroendocrine cancer patients

Neuroendocrine Tumors Clinical Trial 2023: 68Ga-DOTA-TATE Highlights & Side Effects. Trial Name: NCT04847505 — Phase 3

68Ga-DOTA-TATE (Radiopharmaceutical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04847505 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total volume of people who can enroll in this experiment?

"Yes, this is an active trial that was first posted on January 1st 2020. The clinicaltrials.gov website says the study will have one site and aim to enroll 5000 patients."

Answered by AI

Are new patients being allowed to enroll in this research study?

"According to the information available on clinicaltrials.gov, this trial is still in need of participants. The posting date was January 1st 2020 and the most recent update was July 18th 2022. So far, only one location has been admitted into the trial, but they are hoping for 5000 patients total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

68Ga-DOTA-TATE PET/CT Imaging in NETs

Dr Éric E Turcotte, MD 2020. "68Ga-DOTA-TATE PET/CT Imaging in NETs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04847505.

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