A Phase 1 Safety and Dosimetry Study of 68Ga-R8760 in Patients with Adrenocortical Carcinoma and Healthy Volunteers
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
11
PET/CT imaging at predefined timepoints
PET/CT imaging at a single timepoint
University of Michigan Nuclear Medicine
Ann Arbor, Michigan, United States
MD Anderson Cancer Center
Houston, Texas, United States
Incidence of adverse events characterized overall and by type, frequency, seriousness, relationship to study drug, timing and severity graded according to the NCI-CTCAE v5.0; absolute values and changes in clinical laboratory parameters
Time frame: 7 days
Absorbed dose coefficients (milliGray [mGy]/megabecquerel [MBq]) in organs
Time frame: 1 day
The effective dose (milliSievert [mSv]/MBq)
Time frame: 1 day
Number and location of tumors identified by 68Ga-R8760 PET/CT and by anatomic images
Time frame: 1 day
Maximum standard uptake value (SUVmax) of each tumor and of source organ
Time frame: 1 day
Ratio of the tumor SUV over reference region SUV
Time frame: 1 day
Area under the plasma concentration versus time curse (AUC)
Time frame: 1 day
Maximum plasma concentration (Cmax)
Time frame: 1 day
Half-life (T1/2) of 68Ga-R8760
Time frame: 1 day
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