Trial Outcomes & Findings for 18F-Fluoromisonidazole and Fludeoxyglucose F 18 PET/CT Patients With Soft Tissue Sarcoma (NCT NCT01169350)

Results Overview

ANOVA and Kruskal-Wallis analysis will be performed across the different categories to look for significant associations.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

Baseline and up to 2 years

Results posted on

2017-11-17

Participant Flow

Participant milestones

Participant milestones
Measure	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. fludeoxyglucose F 18: Undergo 18F FDG and 18F FMISO PET/CT scans 18F-fluoromisonidazole: Undergo 18F FDG and 18F FMISO PET/CT scans positron emission tomography: Undergo 18F FDG and 18F FMISO PET/CT scans computed tomography: Undergo 18F FDG and 18F FMISO PET/CT scans laboratory biomarker analysis: Correlative studies
Overall Study STARTED	8
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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. fludeoxyglucose F 18: Undergo 18F FDG and 18F FMISO PET/CT scans 18F-fluoromisonidazole: Undergo 18F FDG and 18F FMISO PET/CT scans positron emission tomography: Undergo 18F FDG and 18F FMISO PET/CT scans computed tomography: Undergo 18F FDG and 18F FMISO PET/CT scans laboratory biomarker analysis: Correlative studies
Overall Study Physician Decision	3
Overall Study Lost to Follow-up	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diagnostic (18F FDG and 18F FMISO PET/CT) n=8 Participants 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. fludeoxyglucose F 18: Undergo 18F FDG and 18F FMISO PET/CT scans 18F-fluoromisonidazole: Undergo 18F FDG and 18F FMISO PET/CT scans positron emission tomography: Undergo 18F FDG and 18F FMISO PET/CT scans computed tomography: Undergo 18F FDG and 18F FMISO PET/CT scans laboratory biomarker analysis: Correlative studies
Age, Continuous	61 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and up to 2 years

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

ANOVA and Kruskal-Wallis analysis will be performed across the different categories to look for significant associations.

Outcome measures

Outcome measures
Measure	Diagnostic (18F FDG and 18F FMISO PET/CT) n=3 Participants 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. fludeoxyglucose F 18: Undergo 18F FDG and 18F FMISO PET/CT scans 18F-fluoromisonidazole: Undergo 18F FDG and 18F FMISO PET/CT scans positron emission tomography: Undergo 18F FDG and 18F FMISO PET/CT scans computed tomography: Undergo 18F FDG and 18F FMISO PET/CT scans laboratory biomarker analysis: Correlative studies
Changes From Baseline Hypoxic Volume (HV)	9.7 Cm^3 Standard Deviation 11.7

SECONDARY outcome

Timeframe: Up to 2 years

Population: Study ended. No patients were assessed for overall survival.No data were collected for this assessment.

Multivariate Cox regression will be used. The outcome is binary and generalized linear models and logistic regression will be employed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of treatment to the follow-up review where recurrent disease is first detected, assessed up to 2 years

Population: Study ended. No patients were assessed for disease free survival.No data were collected for this assessment

Multivariate Cox regression will be used.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: Study ended. No patients were assessed for response to radiation therapy (XRT) by RECIST criteria. No data were collected for this assessment.

Will be approached using multivariate logistic regression.

Outcome measures

Outcome data not reported

Adverse Events

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

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Janet F. Eary

University of Washington

Phone: 206-598-6244

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60