NCT07292818 Hyaluronic Acid-based Gel Spacers in Gynecologic Malignancies
| NCT ID | NCT07292818 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | UNC Lineberger Comprehensive Cancer Center |
| Condition | Cervix Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 14 participants |
| Start Date | 2026-02-02 |
| Primary Completion | 2027-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 14 participants in total. It began in 2026-02-02 with a primary completion date of 2027-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This pilot feasibility study evaluates the use of a hyaluronic acid-based spacing gel (Barrigel) in participants with cervical cancer undergoing chemoradiotherapy (chemoRT), including brachytherapy, as part of standard care. The primary goal is to assess feasibility. Other goals include determining whether gel placement can reduce radiation dose to nearby healthy organs (organs at risk, OAR) and improve delivery of the prescribed radiation dose to the tumor. In cervical cancer, the radiation dose to the tumor is often limited by the risk of exposing nearby sensitive organs, such as the rectum, bladder, and other pelvic structures. Vaginal packing techniques and specialized devices are used to protect these organs and ensure effective treatment. Gel spacers are inserted before radiation therapy to create space between the rectum and the cervix, reducing radiation exposure to healthy tissue. Already widely used in prostate cancer treatment in the U.S., gel spacers may also help improve tumor control and reduce treatment-related toxicity in cervical cancer.
Eligibility Criteria
Inclusion Criteria: * Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. * Subject is willing and able to comply with study procedures based on the judgment of the investigator. * Age ≥ 18 years at time of consent. * Eastern Cooperative Oncology Group Performance Status of 0-2 or Karnofsky Performance Scale score of 50-100. * Histological or cytological evidence of cervical cancer. Only patients with cervical cancer who are planned for chemoradiotherapy with brachytherapy, except for individuals with known rectal invasion. Exclusion Criteria: * Active infection requiring systemic therapy. * Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated in the study). * Known allergy to hyaluronic acid-based products. * Known inflammatory bowel disease, such as Crohn's disease or ulcerative colitis.
Contact & Investigator
Shivani Sud, MD
PRINCIPAL INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT07292818 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Cervix Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07292818 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07292818 currently recruiting?
Yes, NCT07292818 is actively recruiting participants. Contact the research team at Melissa_Knutsen@med.unc.edu for enrollment information.
Where is the NCT07292818 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT07292818 clinical trial?
NCT07292818 is sponsored by UNC Lineberger Comprehensive Cancer Center. The principal investigator is Shivani Sud, MD at UNC Lineberger Comprehensive Cancer Center. The trial plans to enroll 14 participants.
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