Trial Outcomes & Findings for 68Ga-PSMA-Dual-Contrast PET/MRI or PET/CT for Early Detection of Liver Cancer (NCT NCT04762888)
NCT ID: NCT04762888
Last Updated: 2026-08-12
Results Overview
Treatment-naïve hepatocellular carcinoma (HCC) lesions were evaluated qualitatively on baseline 68Ga-PSMA-11 PET. Grade 1 indicated uptake less than normal liver. Grade 2 indicated uptake equal to normal liver. Grade 3 indicated uptake greater than normal liver. Grade 4 indicated uptake greater than spleen or kidneys. High PSMA uptake was defined as grade 3 or 4. Low PSMA uptake was defined as grade 1 or 2.
COMPLETED
PHASE2
52 participants
Baseline 68Ga-PSMA-11 PET performed within 4 weeks of recruitment.
2026-08-12
Participant Flow
Participant milestones
| Measure |
Participants With Treatment-Naïve HCC Evaluated for 68Ga-PSMA-11 PET
Patients receive 68Ga-PSMA IV over 90 minutes. Patients then undergo PET/MRI over 60 minutes or PET/CT over 30 minutes.
* Computed Tomography: Undergo PET/CT
* Gallium Ga 68 Gozetotide: Given IV
* Magnetic Resonance Imaging: Undergo PET/MRI
* Positron Emission Tomography: PET/MRI or PET/CT
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Participants With Treatment-Naïve HCC Evaluated for 68Ga-PSMA-11 PET
Patients receive 68Ga-PSMA IV over 90 minutes. Patients then undergo PET/MRI over 60 minutes or PET/CT over 30 minutes.
* Computed Tomography: Undergo PET/CT
* Gallium Ga 68 Gozetotide: Given IV
* Magnetic Resonance Imaging: Undergo PET/MRI
* Positron Emission Tomography: PET/MRI or PET/CT
|
|---|---|
|
Overall Study
Refused further study participation
|
7
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Ineligible
|
5
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
68Ga-PSMA-Dual-Contrast PET/MRI or PET/CT for Early Detection of Liver Cancer
Baseline characteristics by cohort
| Measure |
Participants With Treatment-Naïve HCC Evaluated for 68Ga-PSMA-11 PET
n=52 Participants
Patients receive 68Ga-PSMA IV over 90 minutes. Patients then undergo PET/MRI over 60 minutes or PET/CT over 30 minutes.
Computed Tomography: Undergo PET/CT Gallium Ga 68 Gozetotide: Given IV Magnetic Resonance Imaging: Undergo PET/MRI Positron Emission Tomography: PET/MRI or PET/CT
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=1 Participants
|
|
Age, Categorical
>=65 years
|
34 Participants
n=1 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=1 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=1 Participants
|
PRIMARY outcome
Timeframe: Baseline 68Ga-PSMA-11 PET performed within 4 weeks of recruitment.Population: Outcome data are reported for the published evaluable baseline PET cohort, including participants with completed baseline 68Ga-PSMA-11 PET/MRI or PET/CT and evaluable lesion-level HCC uptake assessment. 39 lesions were assessed for this outcome.
Treatment-naïve hepatocellular carcinoma (HCC) lesions were evaluated qualitatively on baseline 68Ga-PSMA-11 PET. Grade 1 indicated uptake less than normal liver. Grade 2 indicated uptake equal to normal liver. Grade 3 indicated uptake greater than normal liver. Grade 4 indicated uptake greater than spleen or kidneys. High PSMA uptake was defined as grade 3 or 4. Low PSMA uptake was defined as grade 1 or 2.
Outcome measures
| Measure |
Participants With Treatment-Naïve HCC Evaluated for 68Ga-PSMA-11 PET
n=39 HCC Lesions
Patients receive 68Ga-PSMA IV over 90 minutes. Patients then undergo PET/MRI over 60 minutes or PET/CT over 30 minutes.
Computed Tomography: Undergo PET/CT Gallium Ga 68 Gozetotide: Given IV Magnetic Resonance Imaging: Undergo PET/MRI Positron Emission Tomography: PET/MRI or PET/CT
|
|---|---|
|
Number of HCC Lesions With High PSMA Uptake on Baseline 68Ga-PSMA-11 PET
High PSMA uptake, grade 3 or 4
|
25 HCC Lesions
|
|
Number of HCC Lesions With High PSMA Uptake on Baseline 68Ga-PSMA-11 PET
Low PSMA uptake, grade 1 or 2
|
14 HCC Lesions
|
PRIMARY outcome
Timeframe: Baseline 68Ga-PSMA-11 PET performed within 4 weeks of recruitment.Population: Lesion-level SUV metrics are reported for 25 high-PSMA-uptake HCC lesions identified among participants in the evaluable baseline PET cohort.
Semi-quantitative PET metrics were calculated in HCC lesions showing high qualitative PSMA uptake using gradient-based volume-of-interest segmentation. Reported metrics were maximum SUV (SUVmax) and mean SUV (SUVmean).
Outcome measures
| Measure |
Participants With Treatment-Naïve HCC Evaluated for 68Ga-PSMA-11 PET
n=25 HCC Lesions
Patients receive 68Ga-PSMA IV over 90 minutes. Patients then undergo PET/MRI over 60 minutes or PET/CT over 30 minutes.
Computed Tomography: Undergo PET/CT Gallium Ga 68 Gozetotide: Given IV Magnetic Resonance Imaging: Undergo PET/MRI Positron Emission Tomography: PET/MRI or PET/CT
|
|---|---|
|
Semi-Quantitative 68Ga-PSMA-11 PET Standardized Uptake Value (SUV) Metrics in HCC Lesions With High PSMA Uptake
SUV Max
|
9.2 Standardized uptake value
Interval 4.9 to 28.4
|
|
Semi-Quantitative 68Ga-PSMA-11 PET Standardized Uptake Value (SUV) Metrics in HCC Lesions With High PSMA Uptake
SUV Mean
|
4.7 Standardized uptake value
Interval 2.4 to 12.7
|
PRIMARY outcome
Timeframe: Baseline 68Ga-PSMA-11 PET performed within 4 weeks of recruitment.Population: Lesion-level TBR metrics are reported for 25 high-PSMA-uptake HCC lesions identified among participants in the evaluable baseline PET cohort.
Semi-quantitative PET tumor-to-liver background ratio (TBR) metrics were calculated in HCC lesions showing high qualitative PSMA uptake using gradient-based volume-of-interest segmentation. Reported metrics were TBRmax and TBRmean.
Outcome measures
| Measure |
Participants With Treatment-Naïve HCC Evaluated for 68Ga-PSMA-11 PET
n=25 HCC Lesions
Patients receive 68Ga-PSMA IV over 90 minutes. Patients then undergo PET/MRI over 60 minutes or PET/CT over 30 minutes.
Computed Tomography: Undergo PET/CT Gallium Ga 68 Gozetotide: Given IV Magnetic Resonance Imaging: Undergo PET/MRI Positron Emission Tomography: PET/MRI or PET/CT
|
|---|---|
|
Semi-Quantitative 68Ga-PSMA-11 PET Tumor-to-Liver Background Ratio (TBR) Metrics in HCC Lesions With High PSMA Uptake
TBRmax
|
2.0 Ratio
Interval 1.1 to 11.0
|
|
Semi-Quantitative 68Ga-PSMA-11 PET Tumor-to-Liver Background Ratio (TBR) Metrics in HCC Lesions With High PSMA Uptake
TBRmean
|
2.8 Ratio
Interval 1.3 to 10.1
|
Adverse Events
Participants With Treatment-Naïve HCC Evaluated for 68Ga-PSMA-11 PET
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place