← Back to Search

Brachytherapy

Cs-131 Brachytherapy for Recurrent Brain Cancer

Phase 2

Recruiting

Led By Nelson Moss, 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

Karnofsky Performance Status score (KPS) of ≥70

Undergoing elective craniotomy for resection of a previously-irradiated brain metastasis with suspicion for viable disease at the time of consent, and anticipated achievement of gross-total or near-total (≥95%) resection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months following surgery

Awards & highlights

Study Summary

This trial is testing whether Cs-131 brachytherapy, administered during brain surgery, can help prevent brain tumors from recurring. The safety and effectiveness of Cs-131 will be compared to the standard of care, brain surgery without brachytherapy.

Who is the study for?

This trial is for adults over 18 with recurrent brain cancer who can consent, are able to have an MRI, and are scheduled for brain surgery. They should be in good enough health to perform daily activities (KPS ≥70) and not pregnant or breastfeeding. Excluded are those with infections, immunodeficiency, urgent surgery needs, more than six active brain lesions, intolerance to MRI/CT scans or excessive prior radiation.Check my eligibility

What is being tested?

The study tests if Cs-131 brachytherapy during brain surgery helps prevent tumor regrowth compared to standard surgery without it. It's a randomized Phase II trial where the effectiveness and safety of adding Cs-131 at the time of tumor removal will be evaluated against usual surgical care.See study design

What are the potential side effects?

Potential side effects may include risks associated with craniotomy such as infection or bleeding at the site of operation. Specific side effects from Cs-131 brachytherapy could involve localized radiation effects like swelling or damage to surrounding healthy brain tissue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am able to care for myself but may not be able to do active work.

Select...

I am scheduled for surgery to remove a brain tumor that was previously treated with radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months following surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months following surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months following surgery for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

freedom from local progression

Secondary outcome measures

wound complications

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Resection plus brachytherapyExperimental Treatment2 Interventions

Patients will undergo craniotomy and patients in the treatment arm will undergo implantation of Cesium 131 brachytherapy in coordination with the radiation oncologist.

Group II: Resection without brachytherapyActive Control1 Intervention

Patients will undergo craniotomy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Craniotomy

2016

N/A

~740

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,805 Total Patients Enrolled

GT Medical Technologies, Inc.Industry Sponsor

5 Previous Clinical Trials

1,561 Total Patients Enrolled

Nelson Moss, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

2 Previous Clinical Trials

47 Total Patients Enrolled

Media Library

Cesium-131 brachytherapy (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04690348 — Phase 2

Brain Metastases Research Study Groups: Resection without brachytherapy, Resection plus brachytherapy

Brain Metastases Clinical Trial 2023: Cesium-131 brachytherapy Highlights & Side Effects. Trial Name: NCT04690348 — Phase 2

Cesium-131 brachytherapy (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04690348 — Phase 2

Frequently Asked Questions

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

Has the US Food and Drug Administration accepted Cesium-131 brachytherapy as a viable treatment?

"Taking into account the lack of clinical evidence to support its efficacy, our team at Power has given Cesium-131 brachytherapy a score of 2 in regards to safety."

Answered by AI

To what extent is enrollment in this medical study progressing?

"This clinical trial requires 76 patients that fit the inclusion criteria for enrollment. These individuals can be recruited from University of Minnesota in Minneapolis, MN and Memorial Sloan Kettering Commack (Consent Only) in New york to name a few locations."

Answered by AI

How many sites are providing access to this research trial?

"This investigation is currently running at 7 sites, including Minneapolis, Commack and New york. It may be prudent to opt for the closest location in order to curtail one's need to travel if they decide to participate."

Answered by AI

Is there still an opportunity to join this medical research study?

"Affirmative, the data on clinicaltrials.gov reflects that this trial is actively enlisting candidates. It was initially posted in December of 2020 and it has been revised most recently on October 19th 2022. This medical experiment necessitates 76 participants from 7 sites for completion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study

2020. "Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04690348.

All > Brain Metastases