Trial Outcomes & Findings for [18F]FMISO PET/CT After Transcatheter Arterial Embolization in Imaging Tumors in Patients With Liver Cancer (NCT NCT02695628)

Last Updated: 2024-01-31

Results Overview

All participants undergo transcatheter arterial embolization (TACE) and 18F-fluoromisonidazole (18F-FMISO) positron emission tomography (PET)/computed tomography (CT) scans were conducted. Maximum standardized uptake value (SUVmax) were determined at the tumor lesion and in normal tissue, represented by liver. The variability of 18F-FMISO uptake in hepatocellular carcinoma (HCC) tumors post-TACE was assessed as the ratio of the SUVmax as observed in the tumor vs liver (tumor-to-liver ratio, TLR). The outcome is reported as the mean TLR, with standard deviation.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

24 hours

Results posted on

2024-01-31

Participant Flow

Participant milestones

Participant milestones
Measure	Diagnostic (18F-fluoromisonidazole, PET/CT, Embolization) Patients undergo transcatheter arterial embolization. Patients also receive 18F-fluoromisonidazole IV and undergo PET/CT scans 4 weeks prior to embolization treatment and in the 20 hours following completion of treatment. 18F-Fluoromisonidazole: Undergo \[18F\] FMISO PET/CT Arterial Embolization: Undergo transcatheter arterial embolization Computed Tomography: Undergo \[18F\] FMISO PET/CT Positron Emission Tomography: Undergo \[18F\] FMISO PET/CT
Overall Study STARTED	5
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Diagnostic (18F-fluoromisonidazole, PET/CT, Embolization) Patients undergo transcatheter arterial embolization. Patients also receive 18F-fluoromisonidazole IV and undergo PET/CT scans 4 weeks prior to embolization treatment and in the 20 hours following completion of treatment. 18F-Fluoromisonidazole: Undergo \[18F\] FMISO PET/CT Arterial Embolization: Undergo transcatheter arterial embolization Computed Tomography: Undergo \[18F\] FMISO PET/CT Positron Emission Tomography: Undergo \[18F\] FMISO PET/CT
Overall Study Withdrawal by Subject	1

Baseline Characteristics

[18F]FMISO PET/CT After Transcatheter Arterial Embolization in Imaging Tumors in Patients With Liver Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diagnostic (18F-fluoromisonidazole, PET/CT, Embolization) n=5 Participants Patients undergo transcatheter arterial embolization. Patients also receive 18F-fluoromisonidazole IV and undergo PET/CT scans 4 weeks prior to embolization treatment and in the 20 hours following completion of treatment. 18F-Fluoromisonidazole: Undergo \[18F\] FMISO PET/CT Arterial Embolization: Undergo transcatheter arterial embolization Computed Tomography: Undergo \[18F\] FMISO PET/CT Positron Emission Tomography: Undergo \[18F\] FMISO PET/CT
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants
Age, Categorical >=65 years	4 Participants n=93 Participants
Age, Continuous	66.6 Years STANDARD_DEVIATION 5.59 • n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	5 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	4 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	5 participants n=93 Participants
Maximum Standardized Uptake Value (SUVmax) in Tumor vs Normal Tissue	0.71 Ratio STANDARD_DEVIATION 0.22 • n=93 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: Due to withdrawal, not all participants completed for this outcome.

Outcome measures

Outcome measures
Measure	Diagnostic (18F-fluoromisonidazole, PET/CT, Embolization) n=4 Participants Patients undergo transcatheter arterial embolization. Patients also receive 18F-fluoromisonidazole IV and undergo PET/CT scans 4 weeks prior to embolization treatment and in the 20 hours following completion of treatment. 18F-Fluoromisonidazole: Undergo \[18F\] FMISO PET/CT Arterial Embolization: Undergo transcatheter arterial embolization Computed Tomography: Undergo \[18F\] FMISO PET/CT Positron Emission Tomography: Undergo \[18F\] FMISO PET/CT
Post-treatment Maximum Standardized Uptake Value (SUVmax) in Tumor and Normal Tissue	0.76 Ratio Standard Deviation 0.14

SECONDARY outcome

Timeframe: Up to 6 months

Population: Follow-up 18F-fluoromisonidazole (18F-FMISO) positron emission tomography (PET) scans at the time of tumor recurrence were not conducted.

Follow-up 18F-fluoromisonidazole (18F-FMISO) positron emission tomography (PET)/computed tomography (CT) scans were to be conducted within 6 months or at the time of tumor recurrence. Maximum standardized uptake value (SUVmax) were determined at the tumor lesion and in normal tissue, represented by liver. The variability of 18F-FMISO uptake at the hepatocellular carcinoma (HCC) tumor lesion site post-TACE was assessed as the mean difference in the ratio of the SUVmax as observed in the tumor vs liver (tumor-to-liver ratio, TLR), between lesions that recurred, and those that did not. The outcome is reported as the mean TLR, with standard deviation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 hours

Population: All participants are included for this outcome.

Toxicity to 18F-fluoromisonidazole (18F-FMISO) was assessed by the number of adverse events that occurred within 18 hours of administration (about 10 half-lives), that were also unanticipated and related to 18F-FMISO. The outcome is reported as the number of adverse events that were unanticipated and related to 18F-FMISO, a number without dispersion.

Outcome measures

Outcome measures
Measure	Diagnostic (18F-fluoromisonidazole, PET/CT, Embolization) n=5 Participants Patients undergo transcatheter arterial embolization. Patients also receive 18F-fluoromisonidazole IV and undergo PET/CT scans 4 weeks prior to embolization treatment and in the 20 hours following completion of treatment. 18F-Fluoromisonidazole: Undergo \[18F\] FMISO PET/CT Arterial Embolization: Undergo transcatheter arterial embolization Computed Tomography: Undergo \[18F\] FMISO PET/CT Positron Emission Tomography: Undergo \[18F\] FMISO PET/CT
Adverse Events Related to 18F-fluoromisonidazole (18F-FMISO)	0 Number of adverse events

Adverse Events

Diagnostic (18F-fluoromisonidazole, PET/CT, Embolization)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Diagnostic (18F-fluoromisonidazole, PET/CT, Embolization) n=5 participants at risk Patients undergo transcatheter arterial embolization. Patients also receive 18F-fluoromisonidazole IV and undergo PET/CT scans 4 weeks prior to embolization treatment and in the 20 hours following completion of treatment. 18F-Fluoromisonidazole: Undergo \[18F\] FMISO PET/CT Arterial Embolization: Undergo transcatheter arterial embolization Computed Tomography: Undergo \[18F\] FMISO PET/CT Positron Emission Tomography: Undergo \[18F\] FMISO PET/CT
General disorders Fatigue	80.0% 4/5 • Number of events 4 • 6 months
Hepatobiliary disorders Hepatic pain	40.0% 2/5 • Number of events 3 • 6 months
General disorders Edema limbs	20.0% 1/5 • Number of events 1 • 6 months
Gastrointestinal disorders Diarrhea	20.0% 1/5 • Number of events 1 • 6 months
Gastrointestinal disorders Nausea	40.0% 2/5 • Number of events 2 • 6 months
Infections and infestations Infections and infestations -Other, Cellulitis	20.0% 1/5 • Number of events 1 • 6 months
Hepatobiliary disorders Hepatobiliary disorders -Other, increased liver functions	40.0% 2/5 • Number of events 2 • 6 months

Additional Information

Rajesh Shah

Stanford University

Phone: 650-723-0728

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place