68Ga-NOTA-PEG2-RM26 PET/CT, First in Man Study
NCT06147362 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2023-11-27
Summary
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-PEG2-RM26 in prostate cancer patients. A single dose of 2 MBq/kg of 68Ga-NOTA-PEG2-RM26 limited to 100-200 MBq per examination will be given intravenously. Visual and semiquantitative method will be used to assess PET/CT images.
Conditions
Interventions
- DRUG
-
68Ga-NOTA-PEG2-RM26
Single-dose 68Ga-NOTA-PEG2-RM26, a gastrin-releasing peptide receptor antagonist linked with a positron emitting radioisotope intravenously injected into participants before the PET/CT scans.
Sponsors & Collaborators
-
Stockholm South General Hospital
collaborator OTHER -
Uppsala University
collaborator OTHER -
Karolinska University Hospital
lead OTHER
Principal Investigators
-
Jeffrey Yachnin, MD, PhD · Karolinska University Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-01
- Primary Completion
- 2023-12-31
- Completion
- 2023-12-31
Countries
- Sweden
Study Locations
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