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FDG and FMISO PET Hypoxia Evaluation in Cervical Cancer

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ClinicalTrials.gov Identifier: NCT00559377
Recruitment Status : Completed
First Posted : November 16, 2007
Results First Posted : June 26, 2015
Last Update Posted : December 30, 2016
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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Brief Summary:
This phase II trial is studying how well PET scans using fluoromisonidazole F 18 and fludeoxyglucose F 18 work in finding oxygen in tumor cells of patients undergoing treatment for newly diagnosed stage 1B, stage II, stage II, or stage IV cervical cancer. Diagnostic procedures using positron emission tomography (PET scan), fluoromisonidazole F 18, and fludeoxyglucose F 18 to find oxygen in tumor cells may help doctors predict how patients will respond to treatment.

Condition or disease Intervention/treatment Phase
Cervical Adenocarcinoma Cervical Squamous Cell Carcinoma Stage IB Cervical Cancer Stage IIA Cervical Cancer Stage IIB Cervical Cancer Stage III Cervical Cancer Stage IVA Cervical Cancer Stage IVB Cervical Cancer Other: 18F-fluoromisonidazole Radiation: fluorodeoxyglucose F 18 Procedure: positron emission tomography Other: tissue oxygen measurement Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. Test the extent to which fluoromisonidazole F 18 ([^18F] FMISO) uptake predicts survival of patients undergoing therapy for newly diagnosed stage IB-IVB cervical cancer.

SECONDARY OBJECTIVES:

I. Test [^18F] FMISO tumor uptake as an independent predictor of response to therapy and that it provides additional predictive power over fludeoxyglucose F 18 ([^18F] FDG).

II. Test [^18F] FMISO tumor uptake as a predictor of response in a subgroup of patients receiving radiotherapy.

III. Test the relationship between [^18F] FMISO uptake in the primary tumor and the volume of the primary tumor estimated by CT scan.

IV. Test the reproducibility of [^18F] FMISO uptake in tumors by imaging the same patients on sequential days in a test-retest protocol.

V. Compare [^18F] FMISO PET or PET/CT scan with [^18F] FDG PET or PET/CT scan to test whether [^18F] FMISO is an independent predictor of treatment outcome.

OUTLINE:

Patients receive fluoromisonidazole F 18 ([^18F] FMISO) IV over 1 minute followed by PET scanning. Patients undergo a second [^18F] FMISO PET scan 4-8 weeks later. Patients who have not had a prior fludeoxyglucose F 18 ([^18F] FDG) PET scan as part of their routine clinical management undergo [^18F] FDG PET scanning at baseline. A subset of 10 patients undergo two [^18F] FMISO PET scans within a 48-hour period to evaluate the variability (test-retest) of this imaging measurement.

Patients response to therapy is followed periodically until time to disease progression or for 2 years.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase 2 Study of Positron Emission Tomography Imaging With [18F]-Fluoromisonidazole (FMISO) and [18F]-Fluorodeoxyglucose (FDG) for Assessment of Tumor Hypoxia in Cervical Cancer
Study Start Date : November 2007
Actual Primary Completion Date : July 2012
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Diagnostic FMISO AND FDG PET
Patients receive ^18F FMISO IV over 1 minute followed by PET scanning. Patients undergo a second ^18F FMISO PET scan 4-8 weeks later. Patients who have not had a prior ^18F FDG PET scan as part of their routine clinical management undergo ^18F FDG PET scanning at baseline.
 Other: 18F-fluoromisonidazole
Undergo ^18F FMISO PET scan
Other Name: 18F-FMISO

Radiation: fluorodeoxyglucose F 18
Undergo ^18F FDG PET scan
Other Names:
  • 18FDG
  • FDG

Procedure: positron emission tomography
Undergo ^18F-FMISO and ^18F FDG PET scan
Other Names:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed

Other: tissue oxygen measurement
Undergo ^18 F FMISO PET and ^18F FDG PET


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: For up to 2 years ]
    Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the survival outcome variables.

  2. Disease-free Survival (DFS) [ Time Frame: Up to 2 years ]
    Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the disease free survival outcome variables.


Secondary Outcome Measures :
  1. Relationship Between Hypoxia-related IHC Biomarkers and Regional FMISO Uptake in Tumor [ Time Frame: Up to 2 years ]
    The value of the biomarker by IHC analyses relates primarily to validating the information content of FMISO images.

  2. Relationship Between Ki67 and Regional FMISO Uptake in Tumor [ Time Frame: Up to 2 years ]
    The value of the biomarker Ki67 analyses relates primarily to validating the information content of FMISO images.

  3. Response to XRT Using RECIST [ Time Frame: time to disease progression or 2 years following first FMISO scan ]
    Response for the XRT is evaluated by the radiation oncologists as per standard clinical protocols


Eligibility Criteria
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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:

  • Histologically confirmed squamous cell or adenocarcinoma of the uterine cervix

  • Clinical stage IB-IVB by FIGO criteria

    • Size of the primary tumor ≥ 2 cm as assessed by CT scan
  • Measurable disease
  • Scheduled to undergo radiotherapy, chemotherapy, or combined multimodality management
  • No prior cervical cancer diagnosis
  • No known brain metastases
  • ECOG performance status (PS) 0-2 (Karnofsky PS 60-100%)
  • Life expectancy > 12 months
  • Not pregnant
  • No nursing for 24 hours after fluoromisonidazole F 18 ([^18F] FMISO) PET scanning
  • Negative pregnancy test
  • Weight ≤ 400 lbs
  • Sufficiently healthy to undergo cancer treatment
  • Willing to undergo PET scanning with urinary bladder catheterization
  • Leukocytes ≥ 3,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin normal
  • AST/ALT ≤ 2.5 times normal
  • Creatinine normal OR creatinine clearance ≥ 60 mL/min
  • No serious medical co-morbidities that would preclude definitive local therapy
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to [^18F] FMISO

  • No concurrent uncontrolled illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness/social situations that would limit compliance with study requirements.
  • No prior surgery or radiotherapy for cervical cancer
  • Other concurrent investigational agents allowed
Contacts and Locations
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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): NCT00559377


Locations
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United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Joseph Rajendran University of Washington
More Information
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00559377    
Other Study ID Numbers: NCI-2009-00257
NCI-2009-00257 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
UW IRB# 6143 ( Other Identifier: University of Washington Medical Center )
7958 ( Other Identifier: CTEP )
N01CM37008 ( Other Identifier: US NIH Grant/Contract Award Number: )
First Posted: November 16, 2007    Key Record Dates
Results First Posted: June 26, 2015
Last Update Posted: December 30, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Hypoxia
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Uterine Cervical Diseases
Uterine Diseases
Signs and Symptoms, Respiratory
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action