A Pilot Study of Quantitative Tumor Oxygen Measurements in Cervical Cancer
Quantitative Tumor Oxygen Measurements in Cervical Cancer
1 other identifier
observational
10
1 country
1
Brief Summary
This research is studying the level of oxygen in tumors during the brachytherapy procedure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2019
CompletedFirst Posted
Study publicly available on registry
May 31, 2019
CompletedStudy Start
First participant enrolled
July 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2026
ExpectedApril 22, 2026
March 1, 2026
9 months
May 24, 2019
April 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients with a tumor oxygen measurement from at least 1 oxygen sensor catheter
2 years
Secondary Outcomes (4)
Complete Metabolic Response
2 years
Local Tumor Control
2 years
Disease-Specific Survival
2 Years
Overall Survival
2 years
Study Arms (1)
Oxygen Levels in Tumors
-Quantitative oxygen measurements will be obtained in a single field of view using T1 sequences
Eligibility Criteria
All eligible patients will be women with cervical cancer.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin King, MD, PhD
Brigham and Women's Hospital
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 24, 2019
First Posted
May 31, 2019
Study Start
July 16, 2019
Primary Completion
March 30, 2020
Study Completion (Estimated)
December 15, 2026
Last Updated
April 22, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- BCH - Contact the Technology \& Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation
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