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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 30 minutes, 60 minutes and120 minutes post-injection
Awards & highlights
ERD2021 Trial 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.Check my eligibility
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.See study design
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.
ERD2021 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My scans show at least one cancer area not shrinking.
Select...
I am 18 years old or older.
ERD2021 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 30 minutes, 60 minutes and120 minutes post-injection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 30 minutes, 60 minutes and120 minutes post-injection
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Tumor uptake of 68Ga-PSMA
Secondary outcome measures
Effective half-life of 68Ga-PSMA
Radiation dose (mGy)
Tumor heterogeneity
+1 moreERD2021 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
58 Previous Clinical Trials
31,145 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any active cancer except for non-metastatic skin cancer, or my cancer has been in remission for 3 years.I can have a 68Ga-PSMA PET scan within 2 months after my CT scan.My scans show at least one cancer area not shrinking.I have had local treatment for a lesion, but it's not considered for this trial's criteria.I am 18 years old or older.I have a confirmed adenocarcinoma of the esophagus, stomach, bile ducts, or pancreas from a recent CT scan.I am mostly bedridden due to my health condition.
Research Study Groups:
This trial has the following groups:- Group 1: Single arm with 68Ga-PSMA
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does Radiopharmaceutical 68Ga-PSMA pose a threat to human safety?
"Radiopharmaceutical 68Ga-PSMA is considered to be a safe medication based on our team's assessment. Although it is still in Phase 2 clinical trials, there is some data supporting its safety profile with no efficacy data available as of yet."
Answered by AI
Are we currently recruiting people for this experiment?
"This trial appears to be actively recruiting patients, based on the information available on clinicaltrials.gov. The study was first posted on January 17th, 2022 and was most recently updated on that same date."
Answered by AI
How many individuals are being monitored in this clinical trial?
"That is correct. The clinical trial, as advertised on clinicaltrials.gov, is still recruiting patients. This particular study was posted on 1/17/2022 and was edited on the same date. They are looking for a total of 20 volunteers across 1 site."
Answered by AI
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