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A Pilot Study of Quantitative Tumor Oxygen Measurements in Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03970083
Recruitment Status : Active, not recruiting
First Posted : May 31, 2019
Last Update Posted : March 5, 2020
Sponsor:
Information provided by (Responsible Party):
Larissa Lee, MD, Dana-Farber Cancer Institute

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

Condition or disease
Gynecologic Cancer Cervical Cancer

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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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Other
Time Perspective: Other
Official Title: Quantitative Tumor Oxygen Measurements in Cervical Cancer
Actual Study Start Date : July 16, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
Oxygen Levels in Tumors
-Quantitative oxygen measurements will be obtained in a single field of view using T1 sequences



Primary Outcome Measures :
  1. Proportion of patients with a tumor oxygen measurement from at least 1 oxygen sensor catheter [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Complete Metabolic Response [ Time Frame: 2 years ]
    Absence of abnormal FDG uptake at the site of abnormal FDG uptake noted on the pre-treatment FDG-PET study

  2. Local Tumor Control [ Time Frame: 2 years ]
    Tumor control within the radiation field

  3. Disease-Specific Survival [ Time Frame: 2 Years ]
    From start of treatment to time of disease progression or death

  4. Overall Survival [ Time Frame: 2 years ]
    From start of treatment until death due to any cause



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All eligible patients will be women with cervical cancer.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03970083


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Larissa Lee, MD Brigham and Women's Hospital
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Responsible Party: Larissa Lee, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03970083    
Other Study ID Numbers: 17-596
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Larissa Lee, MD, Dana-Farber Cancer Institute:
Gynecologic Cancer
Cervical Cancer
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female