A Pilot Study of Quantitative Tumor Oxygen Measurements in Cervical Cancer (NCT03970083) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Pilot Study of Quantitative Tumor Oxygen Measurements in Cervical Cancer
United States10 participantsStarted 2019-07-16
Plain-language summary
This research is studying the level of oxygen in tumors during the brachytherapy procedure.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Proportion of patients with a tumor oxygen measurement from at least 1 oxygen sensor catheter