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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)

Tracking Information
First Submitted Date  ICMJE November 15, 2007
First Posted Date  ICMJE November 16, 2007
Results First Submitted Date  ICMJE October 29, 2014
Results First Posted Date  ICMJE June 26, 2015
Last Update Posted Date December 30, 2016
Study Start Date  ICMJE November 2007
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2015)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 15, 2007)
  • Overall survival
  • Disease free survival
  • Response to radiotherapy as measured by standard RECIST criteria
Change History Complete list of historical versions of study NCT00559377 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2015)
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2007)
Relationship between hypoxia-related biomarkers (HIF1-α and VEGF by immunohistochemistry [IHC]), proliferation biomarkers (microvascular density, p53, and Ki-67 by IHC), and regional fluoromisonidazole F 18 uptake in tumor
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FDG and FMISO PET Hypoxia Evaluation in Cervical Cancer
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • 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
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Other: 18F-fluoromisonidazole
  • Radiation: fluorodeoxyglucose F 18
  • Procedure: positron emission tomography
  • Other: tissue oxygen measurement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 13, 2014)
16
Original Enrollment  ICMJE
 (submitted: November 15, 2007)
40
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00559377
Other Study ID Numbers  ICMJE 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: )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joseph Rajendran University of Washington
PRS Account National Cancer Institute (NCI)
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP