Trial Outcomes & Findings for Pilot Study to Assess the Potential Clinical Utility of 18F Fluciclovine PET for Cervical and Endometrial Cancer. (NCT NCT03423082)

Results Overview

Metabolic parameter of maximum standard-uptake-value (SUV) will be compared between research Fluciclovine PET and standard-of-care FDG PET to determine lesion metabolic avidity

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

Two weeks

Results posted on

2020-10-28

Participant Flow

Participant milestones

Participant milestones
Measure	18F Fluciclovine PET Scan Subjects with recently biopsy-proven malignancy of the cervix or uterus undergo an 18F fluciclovine PET scan on a hybrid PET/MRI scanner after they have completed a standard-of-care F-18 FDG PET/CT study. 18F fluciclovine: Each subject will receive one IV dose of 18F fluciclovine for PET scanning 18F fluciclovine PET: Each subject will undergo one 18F fluciclovine PET scan on a hybrid PET/MRI scanner
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	18F Fluciclovine PET Scan n=1 Participants Subjects with recently biopsy-proven malignancy of the cervix or uterus undergo an 18F fluciclovine PET scan on a hybrid PET/MRI scanner after they have completed a standard-of-care F-18 FDG PET/CT study. 18F fluciclovine: Each subject will receive one IV dose of 18F fluciclovine for PET scanning 18F fluciclovine PET: Each subject will undergo one 18F fluciclovine PET scan on a hybrid PET/MRI scanner
Age, Categorical <=18 years	0 Participants n=1 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=1 Participants
Age, Categorical >=65 years	0 Participants n=1 Participants
Sex: Female, Male Female	1 Participants n=1 Participants
Sex: Female, Male Male	0 Participants n=1 Participants

PRIMARY outcome

Timeframe: Two weeks

Metabolic parameter of maximum standard-uptake-value (SUV) will be compared between research Fluciclovine PET and standard-of-care FDG PET to determine lesion metabolic avidity

Outcome measures

Outcome measures
Measure	18F Fluciclovine PET Scan n=1 Participants Subjects with recently biopsy-proven malignancy of the cervix or uterus undergo an 18F fluciclovine PET scan on a hybrid PET/MRI scanner after they have completed a standard-of-care F-18 FDG PET/CT study. 18F fluciclovine: Each subject will receive one IV dose of 18F fluciclovine for PET scanning 18F fluciclovine PET: Each subject will undergo one 18F fluciclovine PET scan on a hybrid PET/MRI scanner
Lesion Metabolic Avidity SUV of standard-of-care FDG	21.5 g/dL
Lesion Metabolic Avidity SUV of research Fluciclovine	6.5 g/dL

SECONDARY outcome

Timeframe: One hour

Population: Only one subject measured, so unable to determine optimal time window

The optimal time window for tumor detection (primary, nodal metastasis) relative to physiologic and benign structures will be determined based on time-activity curves of the Fluciclovine PET scan.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One hour

Population: Only one subject measured, so unable to determine correlation of time-activity-curve with histopathology.

The Fluciclovine time-activity curve of the primary tumor (time to peak, uptake intensity, and slope of washout) will be correlated with histopathologic tumor grading.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Two weeks

Population: Only one subject measured, so parameter output of software program would not be appropriate.

Parameters of textural tumor heterogeneity will be compared between Fluciclovine PET and FDG PET, using the open-access LIFEx software. The software allows for an automatic evaluation of more than 50 parameters for textural analyses and shows the result of the best parameters for tumor heterogeneity; however, no specific marker or measure of heterogeneity is be predefined in this process.

Outcome measures

Outcome data not reported

Adverse Events

18F Fluciclovine PET Scan

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

Nghi C. Nguyen, MD, PhD

University of Pittsburgh

Phone: 412-647-0104

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place