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18F-Fluoromisonidazole and Fludeoxyglucose F 18 PET/CT Patients With Soft Tissue Sarcoma

NCT ID: NCT01169350

Last Updated: 2017-11-17

Study Results

Results available

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

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2013-08-31

Brief Summary

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This phase II trial is studying 18F-fluoromisonidazole and fludeoxyglucose F 18 PET/CT scans to see how well they work in assessing oxygen in tumor tissue of patients with soft tissue sarcoma undergoing chemotherapy with or without radiation therapy. Using diagnostic procedures, such as 18F-fluoromisonidazole and fludeoxyglucose F 18 PET scan and CT scan, to find oxygen in tumor cells may help in planning cancer treatment. It may also help doctors predict how well a patient will respond to treatment.

Detailed Description

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PRIMARY OBJECTIVES:

I. Evaluate the potential of 18F-fluoromisonidazole (\[18F\] FMISO) as a non-invasive indicator of tissue hypoxia to provide tumor-imaging data that correlates with tissue markers of hypoxia in patients with soft tissue sarcoma treated with neoadjuvant chemotherapy with or without radiotherapy.

SECONDARY OBJECTIVES:

I. Test \[18F\] FMISO tumor uptake as an independent predictor of patient outcome and if it provides additional predictive power over fludeoxyglucose F 18 PET scan.

II. Test \[18F\] FMISO tumor uptake as a predictor of response in the subgroup of patients treated with radiotherapy and chemotherapy.

III. Test the reproducibility of \[18F\] FMISO uptake in tumors by imaging the same patients on sequential days in a test-retest protocol.

IV. Determine the relationship between hypoxia-related biomarkers (HIF1-a and VEGF), proliferation biomarkers (microvascular density, p53, and Ki-67), and regional \[18F\] FMISO uptake in tumor.

OUTLINE:

Patients undergo fludeoxyglucose F 18 \[18F\] FDG and 18F-fluoromisonidazole (\[18F\] FMISO) positron emission tomography (PET)/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.

NOTE: Some patients may undergo repeat \[18F\] FMISO PET/CT scan within 48 hours after the first \[18F\] FMISO scan to evaluate the variability (test-retest) of this imaging measurement.

Blood samples are collected after completion of \[18F\] FMISO and \[18F\] FDG PET/CT scans for laboratory biomarker studies by IHC assays. Tumor samples from biopsy or surgery are also collected for biomarker studies.

After completion of study procedures, patients are followed up periodically for 2 years.

Conditions

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Recurrent Adult Soft Tissue Sarcoma Stage I Adult Soft Tissue Sarcoma Stage II Adult Soft Tissue Sarcoma Stage III Adult Soft Tissue Sarcoma Stage IV Adult Soft Tissue Sarcoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (18F FDG and 18F FMISO PET/CT)

Patients undergo 18F FDG and 18F FMISO PET/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.

Group Type EXPERIMENTAL

fludeoxyglucose F 18

Intervention Type RADIATION

Undergo 18F FDG and 18F FMISO PET/CT scans

18F-fluoromisonidazole

Intervention Type OTHER

Undergo 18F FDG and 18F FMISO PET/CT scans

positron emission tomography

Intervention Type PROCEDURE

Undergo 18F FDG and 18F FMISO PET/CT scans

computed tomography

Intervention Type PROCEDURE

Undergo 18F FDG and 18F FMISO PET/CT scans

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Interventions

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fludeoxyglucose F 18

Undergo 18F FDG and 18F FMISO PET/CT scans

Intervention Type RADIATION

18F-fluoromisonidazole

Undergo 18F FDG and 18F FMISO PET/CT scans

Intervention Type OTHER

positron emission tomography

Undergo 18F FDG and 18F FMISO PET/CT scans

Intervention Type PROCEDURE

computed tomography

Undergo 18F FDG and 18F FMISO PET/CT scans

Intervention Type PROCEDURE

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed intermediate- or high-grade soft tissue sarcoma

* Biopsy proven or highly suspicious primary or recurrent disease
* Tumor size ≥ 2 cm
* Scheduled to undergo neoadjuvant chemotherapy with or without radiotherapy
* Life expectancy ≥ 12 months
* Negative pregnancy test
* Willing to undergo PET scanning
* Willing to undergo possible urinary bladder catheterization (for patients with pelvic or proximal thigh tumors)
* Able to lie on the imaging table for up to 1.5 hours
* Weight ≤ 400 lbs
* Not pregnant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janet Eary

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Seattle Cancer Care Alliance

Seattle, Washington, United States

Site Status

University of Washington Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2011-01442

Identifier Type: REGISTRY

Identifier Source: secondary_id

8468

Identifier Type: -

Identifier Source: secondary_id

CDR0000665359

Identifier Type: -

Identifier Source: secondary_id

UW-8468

Identifier Type: -

Identifier Source: secondary_id

6971

Identifier Type: OTHER

Identifier Source: secondary_id

8468

Identifier Type: OTHER

Identifier Source: secondary_id

N01CM37008-9-0-0

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2011-01442

Identifier Type: -

Identifier Source: org_study_id