Clinical trial NCT03970083: A Pilot Study of Quantitative Tumor Oxygen Measurements in Cervical Cancer
Official title: Quantitative Tumor Oxygen Measurements in Cervical Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gynecologic Cancer
Cervical Cancer
Keywords: Gynecologic Cancer
Cervical Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2019-05-31
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible patients will be women with cervical cancer.

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.

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

Primary outcomes:
measure: Proportion of patients with a tumor oxygen measurement from at least 1 oxygen sensor catheter
timeFrame: 2 years
Secondary outcomes:
measure: Complete Metabolic Response
timeFrame: 2 years
measure: Local Tumor Control
timeFrame: 2 years
measure: Disease-Specific Survival
timeFrame: 2 Years
measure: Overall Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Martin King, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: