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FDG and FMISO PET Hypoxia Evaluation in Cervical Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00559377
First Posted: November 16, 2007
Last Update Posted: December 30, 2016
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.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  Purpose
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 Intervention 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 16
Study Start Date: November 2007
Study Completion Date: May 2014
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Joseph Rajendran University of Washington
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00559377     History of Changes
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 Submitted: November 15, 2007
First Posted: November 16, 2007
Results First Submitted: October 29, 2014
Results First Posted: June 26, 2015
Last Update Posted: December 30, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Adenocarcinoma
Uterine Cervical Neoplasms
Hypoxia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Signs and Symptoms, Respiratory
Signs and Symptoms
Fluorodeoxyglucose F18
Misonidazole
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents