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68Ga-PSMA PET Imaging for Gastrointestinal Cancer (ERD2021 Trial)

Phase 2
Recruiting
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
An active cancer is defined as at least one lesion identified as stable or progressive neoplastic on CT imaging.
Age 18 years and older
Must not have
ECOG > 3.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 30 minutes, 60 minutes and120 minutes post-injection
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to treat upper gastrointestinal cancers that has minimal side effects.

Who is the study for?
This trial is for adults over 18 in Canada with advanced upper GI cancers, such as adenocarcinoma of the esophagus, stomach, bile ducts, or pancreas. Participants must have at least one stable or progressing tumor visible on a CT scan within the last 8 weeks and be able to undergo a special PET scan within 2 months of that CT scan. Those with poor performance status (ECOG >3), other active cancers except certain skin cancers, pregnant women, or inability to follow study protocols are excluded.
What is being tested?
The trial is testing if patients with upper gastrointestinal cancer can use a new type of PET imaging using Radiopharmaceutical 68Ga-PSMA to see if they're eligible for targeted radiation therapy called Endoradiotherapy (ERT) with another agent called 177Lu-PSMA. This approach aims to deliver radiation directly to cancer cells while sparing healthy tissue.
What are the potential side effects?
While not detailed in this summary, endoradiotherapy like ERT typically has fewer side effects than traditional treatments because it targets only cancer cells; however, potential side effects may include mild reactions at the injection site and temporary changes in blood tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My scans show at least one cancer area not shrinking.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am mostly bedridden due to my health condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 30 minutes, 60 minutes and120 minutes post-injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 30 minutes, 60 minutes and120 minutes post-injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Tumor uptake of 68Ga-PSMA
Secondary study objectives
Effective half-life of 68Ga-PSMA
Radiation dose (mGy)
Tumor heterogeneity
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single arm with 68Ga-PSMAExperimental Treatment1 Intervention
All participants will undergo a PET scan with 68Ga-PSMA

Find a Location

Who is running the clinical trial?

Centre de recherche du Centre hospitalier universitaire de SherbrookeLead Sponsor
61 Previous Clinical Trials
33,494 Total Patients Enrolled

Media Library

Radiopharmaceutical 68Ga-PSMA Clinical Trial Eligibility Overview. Trial Name: NCT05214820 — Phase 2
Esophageal cancer Research Study Groups: Single arm with 68Ga-PSMA
Esophageal cancer Clinical Trial 2023: Radiopharmaceutical 68Ga-PSMA Highlights & Side Effects. Trial Name: NCT05214820 — Phase 2
Radiopharmaceutical 68Ga-PSMA 2023 Treatment Timeline for Medical Study. Trial Name: NCT05214820 — Phase 2
~1 spots leftby Dec 2024
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