Trial Outcomes & Findings for FDG and FMISO PET Hypoxia Evaluation in Cervical Cancer (NCT NCT00559377)

Results Overview

Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the survival outcome variables.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

For up to 2 years

Results posted on

2016-12-30

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	16
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	9

Baseline Characteristics

FDG and FMISO PET Hypoxia Evaluation in Cervical Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Patients n=16 Participants Patients receive \^18F FMISO IV followed by PET scanning. Patients undergo a second \^18F FMISO PET scan 4-8 weeks later.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Gender Female	16 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants

PRIMARY outcome

Timeframe: For up to 2 years

Population: 1 patient has been lost to follow up for survival measures.

Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the survival outcome variables.

Outcome measures

Outcome measures
Measure	2 Year Overall Survival n=15 Participants Patients who have not been declared deceased for 2 years after their last FMISO scan.
Overall Survival (OS)	11 participants still alive after 2 years

PRIMARY outcome

Timeframe: Up to 2 years

Population: 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.

Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the disease free survival outcome variables.

Outcome measures

Outcome measures
Measure	2 Year Overall Survival n=13 Participants Patients who have not been declared deceased for 2 years after their last FMISO scan.
Disease-free Survival (DFS)	10 participants disease-free after 2 years

SECONDARY outcome

Timeframe: Up to 2 years

Population: 11 tissue samples with Hif1, VEGF, p53 and EGFR IHC values were compared to FMISO uptake.

The value of the biomarker by IHC analyses relates primarily to validating the information content of FMISO images.

Outcome measures

Outcome measures
Measure	2 Year Overall Survival n=11 Participants Patients who have not been declared deceased for 2 years after their last FMISO scan.
Relationship Between Hypoxia-related IHC Biomarkers and Regional FMISO Uptake in Tumor Hif1	5 units on a scale 0=low, 8=high Interval 3.0 to 7.0
Relationship Between Hypoxia-related IHC Biomarkers and Regional FMISO Uptake in Tumor VEGF	5 units on a scale 0=low, 8=high Interval 0.0 to 7.0
Relationship Between Hypoxia-related IHC Biomarkers and Regional FMISO Uptake in Tumor p53	7 units on a scale 0=low, 8=high Interval 4.0 to 8.0
Relationship Between Hypoxia-related IHC Biomarkers and Regional FMISO Uptake in Tumor EGFR	7 units on a scale 0=low, 8=high Interval 3.0 to 8.0

SECONDARY outcome

Timeframe: Up to 2 years

Population: 11 tissue samples with Ki67 values were compared to FMISO uptake.

The value of the biomarker Ki67 analyses relates primarily to validating the information content of FMISO images.

Outcome measures

Outcome measures
Measure	2 Year Overall Survival n=11 Participants Patients who have not been declared deceased for 2 years after their last FMISO scan.
Relationship Between Ki67 and Regional FMISO Uptake in Tumor	74 percentage of staining Standard Deviation 18

SECONDARY outcome

Timeframe: time to disease progression or 2 years following first FMISO scan

Population: 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.

Response for the XRT is evaluated by the radiation oncologists as per standard clinical protocols

Outcome measures

Outcome data not reported

Adverse Events

Diagnostic (^18F FMISO PET and ^18F FDG PET)

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

Joseph G Rajendran

UWMC Dept of Radiology

Phone: 206-221-4421

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60