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This research is studying the level of oxygen in tumors during the brachytherapy procedure.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxygen Levels in Tumors | -Quantitative oxygen measurements will be obtained in a single field of view using T1 sequences |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with a tumor oxygen measurement from at least 1 oxygen sensor catheter | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Metabolic Response | Absence of abnormal FDG uptake at the site of abnormal FDG uptake noted on the pre-treatment FDG-PET study | 2 years |
| Local Tumor Control | Tumor control within the radiation field |
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Inclusion Criteria:
Exclusion Criteria:
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All eligible patients will be women with cervical cancer.
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| Name | Affiliation | Role |
|---|---|---|
| Martin King, MD, PhD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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
Data can be shared no earlier than 1 year following the date of publication
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
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| 2 years |
| Disease-Specific Survival | From start of treatment to time of disease progression or death | 2 Years |
| Overall Survival | From start of treatment until death due to any cause | 2 years |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |