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Active, not recruitingNCT03970083Updated Apr 22, 2026

A Pilot Study of Quantitative Tumor Oxygen Measurements in Cervical Cancer

An observational study in Gynecologic Cancer and Cervical Cancer, sponsored by Brigham and Women's Hospital. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-22.

Sponsored by Brigham and Women's Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
10
Ages
18 Years and older
Sex
Female
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Study summary

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

Read the 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.

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Conditions studied

  • Gynecologic Cancer
  • Cervical Cancer

Keywords

  • Gynecologic Cancer
  • Cervical Cancer
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In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's enrollment of 10 is below the median of 220 across 419 observational studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All eligible patients will be women with cervical cancer.

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

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
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Study design

Observational model
Other
Time perspective
Other
Enrollment
10 participants (actual)
Patient registry
No

Groups and cohorts

  • Oxygen Levels in Tumors

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

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What researchers measure

Primary outcomes

  1. Proportion of patients with a tumor oxygen measurement from at least 1 oxygen sensor catheter

    Time frame: 2 years

Secondary outcomes

  1. Complete Metabolic Response

    Absence of abnormal FDG uptake at the site of abnormal FDG uptake noted on the pre-treatment FDG-PET study

    Time frame: 2 years

  2. Local Tumor Control

    Tumor control within the radiation field

    Time frame: 2 years

  3. Disease-Specific Survival

    From start of treatment to time of disease progression or death

    Time frame: 2 Years

  4. Overall Survival

    From start of treatment until death due to any cause

    Time frame: 2 years

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Study locations

1 site
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
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References and documents

Individual participant data

Plan to share: Yes — The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03970083
Lead sponsor
Brigham and Women's Hospital
Responsible party
Martin T. King, MD, PhD (Principal Investigator, Brigham and Women's Hospital) — Principal investigator
First posted
May 31, 2019
Start date
Jul 16, 2019
Primary completion
Mar 30, 2020
Completion
Dec 15, 2026 (estimated)
Last update
Apr 22, 2026

Study contacts

Martin King, MD, PhD
principal investigator · Brigham and Women's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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