FDG and FMISO PET Hypoxia Evaluation in Cervical Cancer

Cervical Adenocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00559377
• Other study ID #: NCI-2009-00257
• Secondary ID: NCI-2009-00257UW
• Status: Completed
• Phase: Phase 2
• First received: November 15, 2007
• Last updated: December 28, 2016
• Start date: November 2007
• Est. completion date: May 2014

Study information

• Verified date: December 2016
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2014
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Squamous Cell
• 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
• Uterine Cervical Neoplasms

Intervention

Other:
• 18F-fluoromisonidazole
Undergo ^18F FMISO PET scan

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

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

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

Locations

Country	Name	City	State
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the survival outcome variables.	For up to 2 years	No
Primary	Disease-free Survival (DFS)	Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the disease free survival outcome variables.	Up to 2 years	No
Secondary	Relationship Between Hypoxia-related IHC Biomarkers and Regional FMISO Uptake in Tumor	The value of the biomarker by IHC analyses relates primarily to validating the information content of FMISO images.	Up to 2 years	No
Secondary	Relationship Between Ki67 and Regional FMISO Uptake in Tumor	The value of the biomarker Ki67 analyses relates primarily to validating the information content of FMISO images.	Up to 2 years	No
Secondary	Response to XRT Using RECIST	Response for the XRT is evaluated by the radiation oncologists as per standard clinical protocols	time to disease progression or 2 years following first FMISO scan	No