← Back to Search

Brachytherapy

Hydrogel Packing System for Cervical Cancer

N/A

Waitlist Available

Led By Kara Romano

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

FIGO IB1 - IVB Staging according to FIGO and TNM guidelines

Karnofsky performance status (KPS) ≥ 70 or ECOG status ≤1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up fractions/radiation treatments 2 - 5: about 1-4 weeks after starting brachytherapy

Awards & highlights

Study Summary

This trial is testing a new, low cost packing system for brachytherapy to see if it is as effective as the standard options, and to understand any associated discomfort and safety concerns.

Who is the study for?

This trial is for adults over 18 with cervical cancer who are planning to receive brachytherapy. They must have a performance status indicating they can carry out daily activities and agree to lifestyle considerations during the study. Those with prior pelvic radiation, hysterectomy, or pregnant/lactating individuals cannot participate.Check my eligibility

What is being tested?

The study compares a new low-cost packing system called 'BrachyGel VHPS' against standard options used in high-dose-rate (HDR) brachytherapy for cervical cancer. It aims to ensure BrachyGel VHPS protects nearby organs from radiation effectively and assesses patient safety and comfort.See study design

What are the potential side effects?

While specific side effects of BrachyGel VHPS aren't detailed, potential risks may include discomfort at the application site, possible allergic reactions to materials in the hydrogel, and typical brachytherapy-related side effects like localized pain or bleeding.

Eligibility Criteria

Inclusion Criteria

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

Select...

My cervical cancer is between stages IB1 and IVB.

Select...

I am mostly able to care for myself and carry out daily activities.

Select...

I am planning to undergo brachytherapy for my cervical cancer treatment.

Select...

My biopsy shows I have cervical cancer.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ fractions/radiation treatments 2 - 5: about 1-4 weeks after starting brachytherapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~fractions/radiation treatments 2 - 5: about 1-4 weeks after starting brachytherapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and fractions/radiation treatments 2 - 5: about 1-4 weeks after starting brachytherapy for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Highest dose of radiation (in Gy) to the rectum and bladder for each patient

Secondary outcome measures

Adverse Events

Highest dose of radiation (in Gy) to the rectum and bladder for each patient at each treatment

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B: BrachyGel in fractions 2 and 4Experimental Treatment1 Intervention

BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5

Group II: Arm A: BrachyGel in fractions 3 and 5Experimental Treatment1 Intervention

BrachyGel VHPS in fractions 3 and 5 and standard packing in fractions 2 and 4

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor

753 Previous Clinical Trials

1,245,010 Total Patients Enrolled

BrachyFoam, LLCUNKNOWN

Kara RomanoPrincipal Investigator - University of Virginia

University of Virginia

Media Library

BrachyGel VHPS (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04499521 — N/A

$Cervical Cancer Research Study Groups: Arm B: BrachyGel in fractions 2 and 4, Arm A: BrachyGel in fractions 3 and 5$

Cervical Cancer Clinical Trial 2023: BrachyGel VHPS Highlights & Side Effects. Trial Name: NCT04499521 — N/A

BrachyGel VHPS (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04499521 — N/A

Frequently Asked Questions

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

Is this medical research actively seeking participants at present?

"Correct. Per the details on clinicaltrials.gov, the trial was initially posted in March of 2021 and is actively recruiting participants at this time. 45 subjects need to be enrolled across 1 site for successful completion of the study."

Answered by AI

What is the highest capacity of participants in this research endeavor?

"Affirmative. Clinicaltrials.gov reveals that this medical investigation is actively seeking out volunteers, with the original posting made on March 17th 2021 and the most recent update dated July 6th 2022. 45 patients must be enrolled across 1 site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Randomized Study to Compare a Hydrogel Packing System to Standard Packing During HDR Brachytherapy for Cervical Cancer

Kara Romano, MD 2021. "A Randomized Study to Compare a Hydrogel Packing System to Standard Packing During HDR Brachytherapy for Cervical Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04499521.

All > Cervical Cancer