FDG and FMISO PET Hypoxia Evaluation in Cervical Cancer

NCT00559377 | Completed Phase 2 Results

• 4 other identifiers: NCI-2009-00257UW IRB# 61437958N01CM37008
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (3)

• Relationship Between Hypoxia-related IHC Biomarkers and Regional FMISO Uptake in Tumor

  Up to 2 years

• Relationship Between Ki67 and Regional FMISO Uptake in Tumor

  Up to 2 years

• Response to XRT Using RECIST

  time to disease progression or 2 years following first FMISO scan

Study Arms (1)

Diagnostic FMISO AND FDG PET

EXPERIMENTAL

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; Radiation: fluorodeoxyglucose F 18; Procedure: positron emission tomography; Other: tissue oxygen measurement

Interventions

18F-fluoromisonidazole OTHER

Undergo \^18F FMISO PET scan

Also known as: 18F-FMISO

Diagnostic FMISO AND FDG PET

fluorodeoxyglucose F 18 RADIATION

Undergo \^18F FDG PET scan

Also known as: 18FDG, FDG

Diagnostic FMISO AND FDG PET

positron emission tomography PROCEDURE

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

Also known as: FDG-PET, PET, PET scan, tomography, emission computed

Diagnostic FMISO AND FDG PET

tissue oxygen measurement OTHER

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

Diagnostic FMISO AND FDG PET

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

fluoromisonidazole; Fluorodeoxyglucose F18; Magnetic Resonance Spectroscopy; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Limitations and Caveats

Small number of subjects enrolled and events limit meaningful statistical analysis.

Results Point of Contact

• Title: Joseph G Rajendran
• Organization: UWMC Dept of Radiology

rajan@u.washington.edu

206-221-4421

Study Officials

• Joseph Rajendran

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2007
• First Posted: November 16, 2007
• Study Start: November 1, 2007
• Primary Completion: July 1, 2012
• Study Completion: May 1, 2014
• Last Updated: December 30, 2016
• Results First Posted: June 26, 2015

Record last verified: 2016-12

Locations

US (1)