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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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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

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

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.

0 / 3Eligibility criteria met