Trial Outcomes & Findings for Role of Interim 18F-FLT PET/CT for Outcome Prediction in Pancreatic Adenocarcinoma (NCT NCT03318497)

Last Updated: 2022-11-08

Results Overview

Change in FLT PET/CT SUV Max after 2 cycles of chemotherapy will be compared to baseline (pre-treatment FLT PET/CT SUV Max)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

Baseline(pre-treatment), 2 cycles after starting chemotherapy (each cycle 14 days)

Results posted on

2022-11-08

Participant Flow

Participant milestones

Participant milestones
Measure	Diagnostic (Interim FLT PET/CT) The experimental 18F-FLT-PET/CT is required to be completed before initiation of chemotherapy. Labs and correlative radiology, as directed per clinical care, are required within 30 days prior to 18F-FLT-PET/CT; and 18F-FDG-PET/CT is required within 30 days before the 18F-FLT-PET/CT. Follow-up will comprise 24 months of standard practice treatment and follow up. * Procedure: Computed Tomography * Drug: 3'-deoxy-3'-\[F-18\] fluorothymidine: \[F-18\]FLT * Other: Laboratory Biomarker Analysis * Procedure: Positron Emission Tomography 3'-deoxy-3'-\[F-18\] fluorothymidine: \[F-18\]FLT: Given IV The experimental 18F-FLT-PET/CT is required to be completed before initiation of chemotherapy. Labs and correlative radiology, as directed per clinical care, are required within 30 days prior to 18F-FLT-PET/CT; and 18F-FDG-PET/CT is required within 30 days before the 18F-FLT-PET/CT. Follow-up will comprise 24 months of standard practice treatment and follow up. Computed Tomography: Undergo PET/CT Positron Emission Tomography: Undergo PET/CT Laboratory Biomarker Analysis: Correlative studies
Overall Study STARTED	6
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Role of Interim 18F-FLT PET/CT for Outcome Prediction in Pancreatic Adenocarcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diagnostic (Interim FLT PET/CT) n=6 Participants The experimental 18F-FLT-PET/CT is required to be completed before initiation of chemotherapy. Labs and correlative radiology, as directed per clinical care, are required within 30 days prior to 18F-FLT-PET/CT; and 18F-FDG-PET/CT is required within 30 days before the 18F-FLT-PET/CT. Follow-up will comprise 24 months of standard practice treatment and follow up. * Procedure: Computed Tomography * Drug: 3'-deoxy-3'-\[F-18\] fluorothymidine: \[F-18\]FLT * Other: Laboratory Biomarker Analysis * Procedure: Positron Emission Tomography 3'-deoxy-3'-\[F-18\] fluorothymidine: \[F-18\]FLT: Given IV The experimental 18F-FLT-PET/CT is required to be completed before initiation of chemotherapy. Labs and correlative radiology, as directed per clinical care, are required within 30 days prior to 18F-FLT-PET/CT; and 18F-FDG-PET/CT is required within 30 days before the 18F-FLT-PET/CT. Follow-up will comprise 24 months of standard practice treatment and follow up. Computed Tomography: Undergo PET/CT Positron Emission Tomography: Undergo PET/CT Laboratory Biomarker Analysis: Correlative studies
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=99 Participants
Age, Categorical >=65 years	5 Participants n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	6 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	6 participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline(pre-treatment), 2 cycles after starting chemotherapy (each cycle 14 days)

Population: Only two of the enrolled subjects completed both 18F-FLT-PET/CT scans.

Change in FLT PET/CT SUV Max after 2 cycles of chemotherapy will be compared to baseline (pre-treatment FLT PET/CT SUV Max)

Outcome measures

Outcome measures
Measure	Diagnostic (Interim FLT PET/CT) n=2 Participants The experimental 18F-FLT-PET/CT is required to be completed before initiation of chemotherapy. Labs and correlative radiology, as directed per clinical care, are required within 30 days prior to 18F-FLT-PET/CT; and 18F-FDG-PET/CT is required within 30 days before the 18F-FLT-PET/CT. Follow-up will comprise 24 months of standard practice treatment and follow up. * Procedure: Computed Tomography * Drug: 3'-deoxy-3'-\[F-18\] fluorothymidine: \[F-18\]FLT * Other: Laboratory Biomarker Analysis * Procedure: Positron Emission Tomography 3'-deoxy-3'-\[F-18\] fluorothymidine: \[F-18\]FLT: Given IV The experimental 18F-FLT-PET/CT is required to be completed before initiation of chemotherapy. Labs and correlative radiology, as directed per clinical care, are required within 30 days prior to 18F-FLT-PET/CT; and 18F-FDG-PET/CT is required within 30 days before the 18F-FLT-PET/CT. Follow-up will comprise 24 months of standard practice treatment and follow up. Computed Tomography: Undergo PET/CT Positron Emission Tomography: Undergo PET/CT Laboratory Biomarker Analysis: Correlative studies
Change From Baseline in Summed Standardized Uptake Value (SUVmax) of Lesion After 2 Cycles of Chemotherapy	27.45 percentage of SUV Max change Interval -35.8 to 90.96

PRIMARY outcome

Timeframe: Baseline(pre-treatment), 2 cycles after starting chemotherapy (each cycle 14 days)

Population: Data was not collected.

Change in FLT PET/CT SUV peak after 2 cycles of chemotherapy will be compared to baseline (pre-treatment FLT PET/CT SUV Peak)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline(pre-treatment), 2 cycles after starting chemotherapy (each cycle 14 days)

Population: Data was not collected

Change in FLT PET/CT Proliferative tumor volume after 2 cycles of chemotherapy (compared to pre-treatment FLT PET/CT proliferative tumor volume)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline(pre-treatment), until date of first observed death, assessed up to 1 year

Proportion of subjects who were alive at 1 year post-treatment is assessed

Outcome measures

Outcome measures
Measure	Diagnostic (Interim FLT PET/CT) n=6 Participants The experimental 18F-FLT-PET/CT is required to be completed before initiation of chemotherapy. Labs and correlative radiology, as directed per clinical care, are required within 30 days prior to 18F-FLT-PET/CT; and 18F-FDG-PET/CT is required within 30 days before the 18F-FLT-PET/CT. Follow-up will comprise 24 months of standard practice treatment and follow up. * Procedure: Computed Tomography * Drug: 3'-deoxy-3'-\[F-18\] fluorothymidine: \[F-18\]FLT * Other: Laboratory Biomarker Analysis * Procedure: Positron Emission Tomography 3'-deoxy-3'-\[F-18\] fluorothymidine: \[F-18\]FLT: Given IV The experimental 18F-FLT-PET/CT is required to be completed before initiation of chemotherapy. Labs and correlative radiology, as directed per clinical care, are required within 30 days prior to 18F-FLT-PET/CT; and 18F-FDG-PET/CT is required within 30 days before the 18F-FLT-PET/CT. Follow-up will comprise 24 months of standard practice treatment and follow up. Computed Tomography: Undergo PET/CT Positron Emission Tomography: Undergo PET/CT Laboratory Biomarker Analysis: Correlative studies
1 Year Overall Survival	67 percentage of subjects

PRIMARY outcome

Timeframe: Baseline(pre-treatment), until date of first observed death, assessed up to 2 years

Proportion of subjects who were alive at 2 years post-treatment is assessed

Outcome measures

Outcome measures
Measure	Diagnostic (Interim FLT PET/CT) n=6 Participants The experimental 18F-FLT-PET/CT is required to be completed before initiation of chemotherapy. Labs and correlative radiology, as directed per clinical care, are required within 30 days prior to 18F-FLT-PET/CT; and 18F-FDG-PET/CT is required within 30 days before the 18F-FLT-PET/CT. Follow-up will comprise 24 months of standard practice treatment and follow up. * Procedure: Computed Tomography * Drug: 3'-deoxy-3'-\[F-18\] fluorothymidine: \[F-18\]FLT * Other: Laboratory Biomarker Analysis * Procedure: Positron Emission Tomography 3'-deoxy-3'-\[F-18\] fluorothymidine: \[F-18\]FLT: Given IV The experimental 18F-FLT-PET/CT is required to be completed before initiation of chemotherapy. Labs and correlative radiology, as directed per clinical care, are required within 30 days prior to 18F-FLT-PET/CT; and 18F-FDG-PET/CT is required within 30 days before the 18F-FLT-PET/CT. Follow-up will comprise 24 months of standard practice treatment and follow up. Computed Tomography: Undergo PET/CT Positron Emission Tomography: Undergo PET/CT Laboratory Biomarker Analysis: Correlative studies
2 Year Overall Survival	33 percentage of subjects

SECONDARY outcome

Timeframe: Baseline (pre-treatment), until date of first observed progression, assessed up to 6 months

Population: 1 subject died and data is not available to be reported

Proportion of subjects who are progression free at 6 months post-treatment is assessed.

Outcome measures

Outcome measures
Measure	Diagnostic (Interim FLT PET/CT) n=5 Participants The experimental 18F-FLT-PET/CT is required to be completed before initiation of chemotherapy. Labs and correlative radiology, as directed per clinical care, are required within 30 days prior to 18F-FLT-PET/CT; and 18F-FDG-PET/CT is required within 30 days before the 18F-FLT-PET/CT. Follow-up will comprise 24 months of standard practice treatment and follow up. * Procedure: Computed Tomography * Drug: 3'-deoxy-3'-\[F-18\] fluorothymidine: \[F-18\]FLT * Other: Laboratory Biomarker Analysis * Procedure: Positron Emission Tomography 3'-deoxy-3'-\[F-18\] fluorothymidine: \[F-18\]FLT: Given IV The experimental 18F-FLT-PET/CT is required to be completed before initiation of chemotherapy. Labs and correlative radiology, as directed per clinical care, are required within 30 days prior to 18F-FLT-PET/CT; and 18F-FDG-PET/CT is required within 30 days before the 18F-FLT-PET/CT. Follow-up will comprise 24 months of standard practice treatment and follow up. Computed Tomography: Undergo PET/CT Positron Emission Tomography: Undergo PET/CT Laboratory Biomarker Analysis: Correlative studies
6 Months Progression Free Survival	40 percentage of subjects

SECONDARY outcome

Timeframe: Baseline(pre-treatment), until date of first observed progression, assessed up to 1 year

Population: 1 subject died and data is not available to be reported

Proportion of subjects who are progression free at 1 year post-treatment is assessed.

Outcome measures

Outcome measures
Measure	Diagnostic (Interim FLT PET/CT) n=5 Participants The experimental 18F-FLT-PET/CT is required to be completed before initiation of chemotherapy. Labs and correlative radiology, as directed per clinical care, are required within 30 days prior to 18F-FLT-PET/CT; and 18F-FDG-PET/CT is required within 30 days before the 18F-FLT-PET/CT. Follow-up will comprise 24 months of standard practice treatment and follow up. * Procedure: Computed Tomography * Drug: 3'-deoxy-3'-\[F-18\] fluorothymidine: \[F-18\]FLT * Other: Laboratory Biomarker Analysis * Procedure: Positron Emission Tomography 3'-deoxy-3'-\[F-18\] fluorothymidine: \[F-18\]FLT: Given IV The experimental 18F-FLT-PET/CT is required to be completed before initiation of chemotherapy. Labs and correlative radiology, as directed per clinical care, are required within 30 days prior to 18F-FLT-PET/CT; and 18F-FDG-PET/CT is required within 30 days before the 18F-FLT-PET/CT. Follow-up will comprise 24 months of standard practice treatment and follow up. Computed Tomography: Undergo PET/CT Positron Emission Tomography: Undergo PET/CT Laboratory Biomarker Analysis: Correlative studies
1 Year Progression Free Survival	40 percentage of subjects

Adverse Events

Diagnostic (Interim FLT PET/CT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kelli Key, PhD

UT Southwestern Medical Center

Phone: 214-648-8152

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place