Recurrent Adult Soft Tissue SarcomaPhase 2NCT01169350

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

A Phase 2 study testing fludeoxyglucose F 18, 18F-fluoromisonidazole and positron emission tomography in people with Recurrent Adult Soft Tissue Sarcoma and Stage I Adult Soft Tissue Sarcoma, run by National Cancer Institute (NCI) at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Recurrent Adult Soft Tissue Sarcoma, Stage I Adult Soft Tissue Sarcoma, Stage II Adult Soft Tissue Sarcoma
What is being tested?: fludeoxyglucose F 18, 18F-fluoromisonidazole and positron emission tomography
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 2 sitesUnited States
Study dates: Feb 2010to Aug 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 11Show fewer

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

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Seattle Cancer Care Alliance
Seattle, Washington, 98109-1023
University of Washington Medical Center
Seattle, Washington, 98195

Other trials in United States

About this study

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 Soft Tissue Sarcoma

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.

Read the detailed description

PRIMARY OBJECTIVES:

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:

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: 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
Being tested: fludeoxyglucose F 18, 18F-fluoromisonidazole, positron emission tomography, computed tomography, laboratory biomarker analysis
Medical subject headings: Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

fludeoxyglucose F 18Radiation
Undergo 18F FDG and 18F FMISO PET/CT scans
18F-fluoromisonidazoleOther
Undergo 18F FDG and 18F FMISO PET/CT scans
positron emission tomographyProcedure or surgery
Undergo 18F FDG and 18F FMISO PET/CT scans
computed tomographyProcedure or surgery
Undergo 18F FDG and 18F FMISO PET/CT scans
laboratory biomarker analysisOther
Correlative studies

Study groups in NCT01169350
Study group	Role	What they receive
Diagnostic (18F FDG and 18F FMISO PET/CT)	Experimental	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. Receives: Radiation: fludeoxyglucose F 18; Other: 18F-fluoromisonidazole; Procedure: positron emission tomography; Procedure: computed tomography; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes From Baseline Hypoxic Volume (HV)
ANOVA and Kruskal-Wallis analysis will be performed across the different categories to look for significant associations.
Measured: Baseline and up to 2 years

Secondary outcomes (3)

Overall Survival
Multivariate Cox regression will be used. The outcome is binary and generalized linear models and logistic regression will be employed.
Measured: Up to 2 years
Disease Free Survival
Multivariate Cox regression will be used.
Measured: From start of treatment to the follow-up review where recurrent disease is first detected, assessed up to 2 years
Response to Radiation Therapy (XRT) by RECIST Criteria
Will be approached using multivariate logistic regression.
Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2010Aug 2013

First posted26 Jul 2010 (estimated)
Study startFeb 2010
Primary completionOct 2011
Study completionAug 2013

Why it stopped: funding source ended earlier than anticipated

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Recurrent Adult Soft Tissue SarcomaStudies of the same condition, open and under way.
More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01169350
Sponsor's protocol ID: NCI-2011-01442
Other IDs: NCI-2011-01442, 8468, CDR0000665359, UW-8468, 6971, 8468, N01CM37008-9-0-0
Status last verified: Oct 2017
First submitted: 23 Jul 2010
Last updated: 17 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Recurrent Adult Soft Tissue Sarcoma trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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 Soft Tissue Sarcoma
ClinicalTrials.gov ID: NCT01169350
Acronym / sponsor ID: NCI-2011-01442
Conditions: 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
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: funding source ended earlier than anticipated
Enrolment: 8 participants (actual)
Lead sponsor: National Cancer Institute (NCI)US National Institutes of Health
Study start: Feb 2010
Primary completion: Oct 2011 (actual)
Study completion: Aug 2013 (actual)
First posted: 26 Jul 2010 (estimated)
Results: Posted 17 Nov 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

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:

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:

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.

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

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Diagnostic (18F FDG and 18F FMISO PET/CT)	Experimental	Radiation: fludeoxyglucose F 18, Other: 18F-fluoromisonidazole, Procedure: positron emission tomography, Procedure: computed tomography, Other: laboratory biomarker analysisPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Histologically confirmed intermediate- or high-grade soft tissue sarcoma
Scheduled to undergo neoadjuvant chemotherapy with or without radiotherapy
Life expectancy ≥ 12 months
Negative pregnancy test
Willing to undergo PET scanning

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
fludeoxyglucose F 18Undergo 18F FDG and 18F FMISO PET/CT scans	Radiation	Diagnostic (18F FDG and 18F FMISO PET/CT)
18F-fluoromisonidazoleUndergo 18F FDG and 18F FMISO PET/CT scans	Other	Diagnostic (18F FDG and 18F FMISO PET/CT)
positron emission tomographyUndergo 18F FDG and 18F FMISO PET/CT scans	Procedure or surgery	Diagnostic (18F FDG and 18F FMISO PET/CT)
computed tomographyUndergo 18F FDG and 18F FMISO PET/CT scans	Procedure or surgery	Diagnostic (18F FDG and 18F FMISO PET/CT)
laboratory biomarker analysisCorrelative studies	Other	Diagnostic (18F FDG and 18F FMISO PET/CT)

Primary outcome

Changes From Baseline Hypoxic Volume (HV)
Time frame: Baseline and up to 2 years
ANOVA and Kruskal-Wallis analysis will be performed across the different categories to look for significant associations.

3 secondary outcomes

Overall Survival
Time frame: Up to 2 years
Disease Free Survival
Time frame: From start of treatment to the follow-up review where recurrent disease is first detected, assessed up to 2 years
Response to Radiation Therapy (XRT) by RECIST Criteria
Time frame: Up to 2 years

Results and safety

Results posted to the registry on 17 Nov 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diagnostic (18F FDG and 18F FMISO PET/CT)	8	3

Primary outcome: Changes From Baseline Hypoxic Volume (HV)

Time frame: Baseline and up to 2 years. Mean (Standard Deviation). Unit: Cm^3

Measure	Diagnostic (18F FDG and 18F FMISO PET/CT) n = 3
Value	9.7 (11.7)

Population analysed: Study ended with 8 patients imaged at baseline and only 3 patients had 18F FMISO following therapy.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected 24hr +/- 4 hours after each administration of [18F] FMISO.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diagnostic (18F FDG and 18F FMISO PET/CT)	0 of 8 (0%)	0 of 8 (0%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janet Eary principal investigator

University of Washington

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes From Baseline Hypoxic Volume (HV) (time frame: Baseline and up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01169350.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.