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Brachytherapy

Intraoperative Radiation Therapy for Abdomino-pelvic Cancer

Phase 1
Waitlist Available
Led By Abraham Wu, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status 0, 1, or 2
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trialtests a new device for radiation therapy (IORT) during surgery for abdominal/pelvic tumors. It may offer better treatment with fewer side effects. Success could mean wider availability.

Who is the study for?
Adults with a life expectancy over 1 year and advanced or recurrent abdominal/pelvic solid tumors suitable for surgery can join. They must be in decent health, not pregnant, agree to use contraception, and have certain blood counts within normal ranges.Check my eligibility
What is being tested?
The trial is testing the CivaSheet device during surgery for treating abdominal and pelvic cancers. It's an FDA-approved intraoperative radiation therapy that could become a more common treatment if this pilot study shows it's easy to use and effective.See study design
What are the potential side effects?
Possible side effects of using the CivaSheet may include typical risks associated with radiation therapy such as skin irritation, fatigue, localized pain or discomfort post-surgery, but specific side effects will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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I am 18 years old or older.
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I am healthy enough and agree to have surgery to remove my disease.
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My cancer in the abdomen or pelvis needs surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
number of successful implantation of the device in patients

Trial Design

1Treatment groups
Experimental Treatment
Group I: surgical resection and intraoperative radiation therapy (IORT)Experimental Treatment3 Interventions
Brachytherapy will be administered using the CivaSheet, a novel permanent LDR palladium-103 (Pd-103) planar brachytherapy device that is applied directly to the surgical resection bed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CivaSheet
2017
Completed Phase 1
~10
Brachytherapy
2007
Completed Phase 3
~2100
surgical resection
2016
Completed Phase 3
~280

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,931 Previous Clinical Trials
597,675 Total Patients Enrolled
CivaTech OncologyIndustry Sponsor
6 Previous Clinical Trials
292 Total Patients Enrolled
Abraham Wu, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
80 Total Patients Enrolled

Frequently Asked Questions

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

Has CivaSheet been granted regulatory approval by the FDA?

"There is limited evidence to support the safety and efficacy of CivaSheet, therefore it was rated a 1 on our scale at Power."

Answered by AI

Are there any open spots for enrolment in this experiment?

"According to information on clinicaltrials.gov, this particular medical trial is not presently recruiting patients; the posting date was September 1st 2016 and it has been revised as recently as October 19th 2022. However, there are 2380 other studies actively searching for participants at present."

Answered by AI
~2 spots leftby Sep 2025