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Trial Outcomes & Findings for 68-Ga-RM2 PET/MRI in Imaging Patients With Estrogen Receptor-Positive Breast Cancer (NCT NCT03831711)

NCT ID: NCT03831711

Last Updated: 2023-12-13

Results Overview

Number of lesions identified on 68-Ga RM2 positron emission tomography/magnetic resonance imaging (PET/MRI). The outcome will be reported as the number of participants with successful PET based detection of estrogen receptor (ER) positive breast cancer and metastases.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

5 participants

Primary outcome timeframe

up to 2 hours

Results posted on

2023-12-13

Participant Flow

Participant milestones

Participant milestones
Measure
Diagnostic (68-Ga RM2, PET/MRI)
Patients received 68-Ga RM2 IV and after 45 minutes undergo PET/MRI over 30-60 minutes.
Overall Study
STARTED
5
Overall Study
COMPLETED
5
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

68-Ga-RM2 PET/MRI in Imaging Patients With Estrogen Receptor-Positive Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Diagnostic (68-Ga RM2, PET/MRI)
n=5 Participants
Patients received 68-Ga RM2 IV and after 45 minutes undergo PET/MRI over 30-60 minutes.
Age, Continuous
55.6 years
n=5 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
5 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
4 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
5 Participants
n=5 Participants

PRIMARY outcome

Timeframe: up to 2 hours

Number of lesions identified on 68-Ga RM2 positron emission tomography/magnetic resonance imaging (PET/MRI). The outcome will be reported as the number of participants with successful PET based detection of estrogen receptor (ER) positive breast cancer and metastases.

Outcome measures

Outcome measures
Measure
Diagnostic (68-Ga RM2, PET/MRI)
n=5 Participants
Patients received 68-Ga RM2 IV and after 45 minutes undergo PET/MRI over 30-60 minutes.
Detection of ER Positive Breast Cancer and Metastases on 68-Ga RM2 PET/MRI
Breast Lesions
4 Participants
Detection of ER Positive Breast Cancer and Metastases on 68-Ga RM2 PET/MRI
Lymph Node Lesions
1 Participants

Adverse Events

Diagnostic (68-Ga RM2, PET/MRI)

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

Dr. Andrei Iagaru, MD

Stanford University

Phone: 650-725-4711

Results disclosure agreements

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