A Pilot Study of Quantitative Tumor Oxygen Measurements in Cervical Cancer

NCT ID: NCT03970083

Last Updated: 2024-10-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-16
• Study Completion Date: 2025-09-30

Brief Summary

This research is studying the level of oxygen in tumors during the brachytherapy procedure.

Detailed Description

Tumors with low levels of oxygen have been found to be more resistant to standard radiation and chemotherapy treatments. For patients with tumors with low oxygen levels, it is not well known if higher radiation doses can overcome treatment resistance to radiation. Currently, there are limited ways of measuring tumor oxygen levels. The investigators believe that measuring tumor oxygen levels during the brachytherapy procedure will allow the investigators to develop better and improved oxygen measurement techniques, and ultimately improve clinical outcomes for patients, such as better local tumor control.

This research study is a Pilot Study, meaning that this is the first time investigators are examining the oxygen sensor being used. This study is designed to test the oxygen sensor's ability to measure the oxygen levels within the participant's cervical tumor with the aid of magnetic resonance imaging (MRI) scans. MRI scans use magnets to make detailed images of the participant's tumor and the surrounding normal tissues during the brachytherapy procedure.

Conditions

Gynecologic Cancer; Cervical Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

Oxygen Levels in Tumors

-Quantitative oxygen measurements will be obtained in a single field of view using T1 sequences

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Participants must have a biopsy-proven diagnosis of cervical cancer for which interstitial brachytherapy is planned as standard treatment
• Age 18 years or older
• ECOG performance status of 2 or less (see Appendix A)
• Patients who have received prior radiation or chemotherapy may be enrolled on this study
• Participant is deemed to be an appropriate candidate for MR-guided brachytherapy by the radiation oncologist and the patient elects to be treated with MR-guided brachytherapy
• Participant provides informed consent for prospective collection of relevant medical records for analysis of clinical outcome and treatment-planning techniques
• Ability to understand and the willingness to sign a written informed consent document. Participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow- up

Exclusion Criteria

• Participants who have a contraindication to MRI identified by the MR procedure screening form, such as a pacemaker, aneurysm clip, inner ear implant, neurostimulator, or other non-MR-compatible device or implant
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Martin King, MD, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin King, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

17-596

Identifier Type: -

Identifier Source: org_study_id