Trial Outcomes & Findings for PET/CT-Assessment of Liver Tumor Ablation (NCT NCT02018107)

Results Overview

For FDG-avid tumors, compare the rates of complete, circumferential ablation margin visibility during FDG PET/CT-guided liver ablations using two imaging techniques: intra-procedural AP-PET-1(research scan #1) and post-procedural contrast enhanced MRI . Discordance rates for complete ablation margin visibility between the two imaging techniques will be calculated.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

33 participants

Primary outcome timeframe

2 Years

Results posted on

2020-03-26

Participant Flow

33 unique participants were enrolled and consented for this study, 6 participants were then excluded from the study. Thus, the count of subjects is 27 who were assigned to intervention. Out of 27 participants, 1 subject participated in both interventions.

33 unique participants were enrolled and consented for this study, 6 participants were then excluded from the study. Thus, the count of subjects is 27. Out of 27 participants, 1 subject participated in both interventions.

Participant milestones

Participant milestones
Measure	N-13 Ammonia to Image Liver PET Perfusion This single-arm study involves the non-therapeutic administration of a radiopharmaceutical, N-13 ammonia or F-18 fluorodeoxyglucose, one to two doses, during the tumor ablation procedure. The N-13 ammonia perfusion PET scan is a diagnostic imaging test. The tumor ablation procedure is performed according to our standard clinical practice and is not itself a research activity. The use of N-13 ammonia to image liver perfusion with a PET scanner is the research portion of the procedure. The participant will receive one or two IV doses of N-13 ammonia (10 mCi/dose) for intraprocedural assessment of ablation results. Not more than two doses will be administered and one or both doses will be administered on the day of the tumor ablation procedure only N-13 ammonia or F-18 fluorodeoxyglucose: PET tracer PET scan: PET scan
Overall Study STARTED	27
Overall Study COMPLETED	27
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	N-13 Ammoniaor F-18 Fluorodeoxygl to Image Liver PET Perfusion n=27 Participants This single-arm study involves the non-therapeutic administration of a radiopharmaceutical, N-13 ammonia or F-18 fluorodeoxyglucose, one to two doses, during the tumor ablation procedure. The N-13 ammonia perfusion PET scan is a diagnostic imaging test. The tumor ablation procedure is performed according to our standard clinical practice and is not itself a research activity. The use of N-13 ammonia to image liver perfusion with a PET scanner is the research portion of the procedure. The participant will receive one or two IV doses of N-13 ammonia (10 mCi/dose) for intraprocedural assessment of ablation results. Not more than two doses will be administered and one or both doses will be administered on the day of the tumor ablation procedure only N-13 ammonia or F-18 fluorodeoxyglucose: PET tracer PET scan: PET scan
Age, Categorical <=18 years	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=27 Participants
Age, Categorical >=65 years	13 Participants n=27 Participants
Sex: Female, Male Female	13 Participants n=27 Participants
Sex: Female, Male Male	14 Participants n=27 Participants
Region of Enrollment United States	27 participants n=27 Participants

PRIMARY outcome

Timeframe: 2 Years

Population: In this study, the number of tumors were analysed. There 8 participants with 11 tumors that were analysed for N-13 ammonia to image liver PET perfusion and 31 tumors in 20 patients were analysed in F-18 fluorodeoxyglucose to image liver PET perfusion. 1 participant participated in both interventions. Total unique participants 27.

For FDG-avid tumors, compare the rates of complete, circumferential ablation margin visibility during FDG PET/CT-guided liver ablations using two imaging techniques: intra-procedural AP-PET-1(research scan #1) and post-procedural contrast enhanced MRI . Discordance rates for complete ablation margin visibility between the two imaging techniques will be calculated.

Outcome measures

Outcome measures
Measure	N-13 Ammonia or F-18 to Image Liver PET Perfusion n=42 Tumors This single-arm study involves the non-therapeutic administration of a radiopharmaceutical, N-13 ammonia or F-18 fluorodeoxyglucose, one to two doses, during the tumor ablation procedure. The N-13 ammonia perfusion PET scan is a diagnostic imaging test. The tumor ablation procedure is performed according to our standard clinical practice and is not itself a research activity. The use of N-13 ammonia to image liver perfusion with a PET scanner is the research portion of the procedure. The participant will receive one or two IV doses of N-13 ammonia (10 mCi/dose) for intraprocedural assessment of ablation results. Not more than two doses will be administered and one or both doses will be administered on the day of the tumor ablation procedure only N-13 ammonia or F-18 fluorodeoxyglucose: PET tracer PET scan: PET scan
Number and Percentage of Tumors With Complete, Circumferential Ablation Margin Visibility During FDG PET/CT-guided Liver Ablations (AP-PET-1 v. Contrast-enhanced MRI) Total Tumors	42 Tumors
Number and Percentage of Tumors With Complete, Circumferential Ablation Margin Visibility During FDG PET/CT-guided Liver Ablations (AP-PET-1 v. Contrast-enhanced MRI) Assessibility of ablation margin by Pet Perfusion	40 Tumors
Number and Percentage of Tumors With Complete, Circumferential Ablation Margin Visibility During FDG PET/CT-guided Liver Ablations (AP-PET-1 v. Contrast-enhanced MRI) Assessibility of ablation margin by MRI	25 Tumors

SECONDARY outcome

Timeframe: 2 Years

Percentage of tumors with an inadequate margin on PET that progressed locally? Compare to MRI?

Outcome measures

Outcome measures
Measure	N-13 Ammonia or F-18 to Image Liver PET Perfusion n=42 Tumors This single-arm study involves the non-therapeutic administration of a radiopharmaceutical, N-13 ammonia or F-18 fluorodeoxyglucose, one to two doses, during the tumor ablation procedure. The N-13 ammonia perfusion PET scan is a diagnostic imaging test. The tumor ablation procedure is performed according to our standard clinical practice and is not itself a research activity. The use of N-13 ammonia to image liver perfusion with a PET scanner is the research portion of the procedure. The participant will receive one or two IV doses of N-13 ammonia (10 mCi/dose) for intraprocedural assessment of ablation results. Not more than two doses will be administered and one or both doses will be administered on the day of the tumor ablation procedure only N-13 ammonia or F-18 fluorodeoxyglucose: PET tracer PET scan: PET scan
Does an Inadequate Ablation Margin on PET Predict Local Progression? Compare to MRI? PET:% local progression based on inadequate margin	53.84 percentage of tumors
Does an Inadequate Ablation Margin on PET Predict Local Progression? Compare to MRI? MRI:% local progression based on Inadequate margin	83.33 percentage of tumors
Does an Inadequate Ablation Margin on PET Predict Local Progression? Compare to MRI? PET: % local non-progression per adequate margin	96.29 percentage of tumors
Does an Inadequate Ablation Margin on PET Predict Local Progression? Compare to MRI? MRI: % local non-progression per adequate margin	89.47 percentage of tumors

Adverse Events

N-13 Ammonia to Image Liver PET Perfusion

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

Paul Shyn, MD

Brigham & Women's Hospital INC

Phone: 6177326304

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place