MedDataX Logo

FDG and FMISO PET Hypoxia Evaluation in Cervical Cancer

NCT ID: NCT00559377

Last Updated: 2016-12-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2014-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

18F-fluoromisonidazole

Intervention Type OTHER

Undergo \^18F FMISO PET scan

fluorodeoxyglucose F 18

Intervention Type RADIATION

Undergo \^18F FDG PET scan

positron emission tomography

Intervention Type PROCEDURE

Undergo \^18F-FMISO and \^18F FDG PET scan

tissue oxygen measurement

Intervention Type OTHER

Undergo \^18 F FMISO PET and \^18F FDG PET

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

18F-fluoromisonidazole

Undergo \^18F FMISO PET scan

Intervention Type OTHER

fluorodeoxyglucose F 18

Undergo \^18F FDG PET scan

Intervention Type RADIATION

positron emission tomography

Undergo \^18F-FMISO and \^18F FDG PET scan

Intervention Type PROCEDURE

tissue oxygen measurement

Undergo \^18 F FMISO PET and \^18F FDG PET

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

18F-FMISO 18FDG FDG FDG-PET PET PET scan tomography, emission computed

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Joseph Rajendran

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Washington Medical Center

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2009-00257

Identifier Type: REGISTRY

Identifier Source: secondary_id

UW IRB# 6143

Identifier Type: OTHER

Identifier Source: secondary_id

7958

Identifier Type: OTHER

Identifier Source: secondary_id

N01CM37008

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2009-00257

Identifier Type: -

Identifier Source: org_study_id