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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-fluoromisonidazole | Other | Undergo ^18F FMISO PET scan |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Relationship Between Ki67 and Regional FMISO Uptake in Tumor |
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Inclusion Criteria:
Histologically confirmed squamous cell or adenocarcinoma of the uterine cervix
Clinical stage IB-IVB by FIGO criteria
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:
No prior surgery or radiotherapy for cervical cancer
Other concurrent investigational agents allowed
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Rajendran | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic (^18F FMISO PET and ^18F FDG PET) | Patients receive ^18F FMISO IV 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| fluorodeoxyglucose F 18 | Radiation | Undergo ^18F FDG PET scan |
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| positron emission tomography | Procedure | Undergo ^18F-FMISO and ^18F FDG PET scan |
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| tissue oxygen measurement | Other | Undergo ^18 F FMISO PET and ^18F FDG PET |
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The value of the biomarker Ki67 analyses relates primarily to validating the information content of FMISO images. |
| Up to 2 years |
| 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | Patients receive ^18F FMISO IV followed by PET scanning. Patients undergo a second ^18F FMISO PET scan 4-8 weeks later. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Gender | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | 1 patient has been lost to follow up for survival measures. | Posted | Number | participants still alive after 2 years | For up to 2 years |
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| 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. | Of the 13 patients analyzed for disease-free survival, 10 remained disease-free throughout the 2 year follow up. For 3 patients, we could determine overall survival, but could not confirm whether or not they were disease-free. | Posted | Number | participants disease-free after 2 years | Up to 2 years |
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| 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. | 11 tissue samples with Hif1, VEGF, p53 and EGFR IHC values were compared to FMISO uptake. | Posted | Median | Full Range | units on a scale 0=low, 8=high | Up to 2 years |
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| 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. | 11 tissue samples with Ki67 values were compared to FMISO uptake. | Posted | Mean | Standard Deviation | percentage of staining | Up to 2 years |
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| Secondary | Response to XRT Using RECIST | Response for the XRT is evaluated by the radiation oncologists as per standard clinical protocols | PET/CT acquisition was obtained using non-diagnostic low dose CT attenuation scans at the time of PET/CT imaging that limited our ability to accurately measure tumor dimensions and due to lack of complete data, we were not able to fulfill this aim. | Posted | time to disease progression or 2 years following first FMISO scan |
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As a PET imaging study, AEs are assessed at 3 hours post injection (end of the scan) and up to 10 hours following the scan
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diagnostic (^18F FMISO PET and ^18F FDG PET) | Patients receive ^18F FMISO IV 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. | 0 | 16 | 0 | 16 |
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Small number of subjects enrolled and events limit meaningful statistical analysis.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph G Rajendran | UWMC Dept of Radiology | 206-221-4421 | rajan@u.washington.edu |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C031843 | fluoromisonidazole |
| D019788 | Fluorodeoxyglucose F18 |
| D009682 | Magnetic Resonance Spectroscopy |
| C062942 | 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole |
| ID | Term |
|---|---|
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| .87 |
| Hazard Ratio (HR) |
| 1.05 |
| 2-Sided |
| No |
| Superiority or Other |
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