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Trial Outcomes & Findings for [68Ga]DOTATATE-PET/MRI in Hepatocellular Carcinoma (NCT NCT03648073)

NCT ID: NCT03648073

Last Updated: 2023-01-10

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

12 participants

Primary outcome timeframe

1 PET/MRI scan

Results posted on

2023-01-10

Participant Flow

Participant milestones

Participant milestones
Measure
Patients With Radiographic Evidence of HCC on CT or MR
\[68Ga\]DOTATATE-PET/MRI in Hepatocellular Carcinoma \[68Ga\]DOTATATE-PET/MRI: \[68Ga\]DOTATATE-PET/MRI
Overall Study
STARTED
12
Overall Study
COMPLETED
12
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

[68Ga]DOTATATE-PET/MRI in Hepatocellular Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Patients With Radiographic Evidence of HCC on CT or MR
n=12 Participants
\[68Ga\]DOTATATE-PET/MRI in Hepatocellular Carcinoma \[68Ga\]DOTATATE-PET/MRI: \[68Ga\]DOTATATE-PET/MRI
Age, Categorical
<=18 years
0 Participants
n=39 Participants
Age, Categorical
Between 18 and 65 years
7 Participants
n=39 Participants
Age, Categorical
>=65 years
5 Participants
n=39 Participants
Sex: Female, Male
Female
4 Participants
n=39 Participants
Sex: Female, Male
Male
8 Participants
n=39 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=39 Participants
Race (NIH/OMB)
Asian
0 Participants
n=39 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=39 Participants
Race (NIH/OMB)
Black or African American
3 Participants
n=39 Participants
Race (NIH/OMB)
White
9 Participants
n=39 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=39 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=39 Participants
Region of Enrollment
United States
12 participants
n=39 Participants

PRIMARY outcome

Timeframe: 1 PET/MRI scan

Outcome measures

Outcome measures
Measure
Patients With Radiographic Evidence of HCC on CT or MR
n=12 Participants
\[68Ga\]DOTATATE-PET/MRI in Hepatocellular Carcinoma \[68Ga\]DOTATATE-PET/MRI: \[68Ga\]DOTATATE-PET/MRI
Number of Patients Demonstrating Somatostatin Receptor Positivity in Hepatocellular Carcinoma Using [68Ga]DOTATATE-PET
0 Participants

Adverse Events

Patients With Radiographic Evidence of HCC on CT or MR

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

Samuel Galgano, Principal Investigator

University of Alabama at Birmingham

Phone: 2059341449

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place