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FDG Tumor Heterogeneity During Chemoradiation as a Predictor of Response in Patients With 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: NCT02317302
Recruitment Status : Terminated (Insufficient funding)
First Posted : December 16, 2014
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
In this study, 50 evaluable patients will undergo one FDG-PET study during their chemoradiation, in addition to the standard of care pretreatment and 3-month post-treatment clinical FDG-PET/CT or FDG-PET/MR scans. From all FDG-PET studies, tumor volume, SUVmax, FDGhetero, and texture maps will be obtained. Evaluating the changes in tumor SUVmax and heterogeneity during treatment will aid in better understanding the role of these biological parameters in inadequate response to chemoradiation. Other researchers, using MRI imaging, have evaluated changes in the cervical tumor volume during treatment. The investigators expect there will be variation in how cervical tumors shrink and change during chemoradiation and therefore we are going to use multiple measures in addition to tumor volume to evaluate cervical tumor metabolic heterogeneity. Being able to predict at diagnosis the patients who are at higher risk for persistent disease following chemoradiation would allow for future studies where these high risk patients could be specifically targeted with more aggressive therapy.

Condition or disease Intervention/treatment Phase
Cervical Cancer Uterine Cervical Cancer Uterine Cervical Neoplasms Device: FDG-PET/MR Device: FDG-PET/CT Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: FDG Tumor Heterogeneity During Chemoradiation as a Predictor of Response to Concurrent Radiation Therapy and Chemotherapy in Patients With Cervical Cancer
Actual Study Start Date : June 28, 2011
Actual Primary Completion Date : June 2, 2020
Actual Study Completion Date : June 2, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Experimental: FDG-PET/CT or FDG-PET/MR
  • Standard of care FDG-PET/CT or FDG-PET/MR at baseline
  • FDG-PET/CT or FDG-PET/MR after the 2nd but before the 3rd brachytherapy treatment
  • Standard of care 3 month post treatment FDG-PET/CT or FDG-PET/MR
  • We will perform the research-related FDG-PET on the PET/MR rather than the PET/CT if the patient is safe to undergo MR and agrees to undergo MR.
  • The standard of care imaging may be performed on the PET/CT scanner or the PET/MR scanner.
Device: FDG-PET/MR
Other Name: PET/MR

Device: FDG-PET/CT
Other Name: PET/CT




Primary Outcome Measures :
  1. Change in FDG heterogeneity (Using texture analysis) [ Time Frame: Up to 5 years ]
    Using texture analysis

  2. Change in SUVmax (SUVmax - maximum standardized uptake value = is a marker of tumor glucose metabolism and reflects tumor aggressiveness) [ Time Frame: Up to 5 years ]
    SUVmax - maximum standardized uptake value = is a marker of tumor glucose metabolism and reflects tumor aggressiveness.


Secondary Outcome Measures :
  1. Response to therapy based on FDG heterogeneity [ Time Frame: Up to 5 years ]
  2. Response to therapy based on SUVmax [ Time Frame: Up to 5 years ]


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
Criteria

Inclusion Criteria:

  • Patient must have biopsy-proven cervical cancer (FIGO stage-Ib2-IVb).
  • Patient must be at least18 years of age.
  • Patient must be planning to receive chemoradiation therapy with cisplatin.
  • Patient must have non-pregnant status if a female of childbearing potential. Women who have had a tubal ligation at least 12 months prior to study entry or a hysterectomy will be considered NOT of childbearing potential. Postmenopausal women must have been amenorrheic for at least 12 consecutive months to be considered NOT of childbearing potential.
  • Patient may have distant metastatic disease provided the estimated survival is at least 1 year.
  • Patient's tumor(s) must be FDG avid on baseline standard of care FDG-PET/CT or PET/MR imaging that was performed at Barnes-Jewish Hospital Clinical PET Facility.
  • Patient must be able and willing to give informed consent.
  • If the patient will be scanned on the PET/MR for the mid-treatment scan, they must be determined to be safe for exposure to the magnetic field. This will be determined the day of imaging by the technologist with the use of a screening form. If a patient is not safe for the PET/MR scanner, their mid-treatment images will occur on the PET/CT scanner in the Center for Clinical Imaging Research.

Exclusion Criteria:

  • Patient must have no other active cancer at the time of diagnosis of cervical cancer.
  • Patient cannot have received treatment for any malignancy, with the exception of non-melanoma skin cancer, in the past 5 years.
  • Patient must not be an uncontrolled diabetic with a glucose of ≥ 200mg/dl at the time of PET imaging.

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): NCT02317302


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Perry Grigsby, M.D. Washington University School of Medicine
Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02317302    
Other Study ID Numbers: 201104322
First Posted: December 16, 2014    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
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