Clinical trial · Observational
A Pilot Study of Quantitative Tumor Oxygen Measurements in Cervical Cancer
Quantitative Tumor Oxygen Measurements in Cervical Cancer
NCT03970083CI-TRIAL-00109109active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This research is studying the level of oxygen in tumors during the brachytherapy procedure.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Oxygen Levels in Tumors
- description
- -Quantitative oxygen measurements will be obtained in a single field of view using T1 sequences
Primary outcomes (1)
- measure
- Proportion of patients with a tumor oxygen measurement from at least 1 oxygen sensor catheter
- timeFrame
- 2 years
Secondary outcomes (4)
- measure
- Complete Metabolic Response
- timeFrame
- 2 years
- description
- Absence of abnormal FDG uptake at the site of abnormal FDG uptake noted on the pre-treatment FDG-PET study
- measure
- Local Tumor Control
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.