Status:
UNKNOWN
68Ga-NOTA-PEG2-RM26 PET/CT, First in Man Study
Lead Sponsor:
Karolinska University Hospital
Collaborating Sponsors:
Stockholm South General Hospital
Uppsala University
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 patien...
Detailed Description
The gastrin-releasing peptide receptor (GRPR), also known as bombesin receptor subtype II (BB2), is a member of the G protein-coupled receptor family of bombesin receptors. GRPR is over-expressed in v...
Eligibility Criteria
Inclusion
- Primary/recurrent or metastatic cancer in: prostate cancer, breast cancer, colorectal cancer, gastrointestinal carcinoid, gastric cancer, or lung cancer
- Histopathological diagnosis
- Age 18 years or more and palliative disease OR age above 50 years
- Adequate bone marrow, hepatic and renal function, Eastern Cooperative Oncology Group Performance Status Scale 0 or 1 and a negative pregnancy test
Exclusion
- Age less than 18 years
- Less than 6 months since a clinically significant cardiovascular event such as myocardial infarction, unstable angina, angioplasty, bypass surgery, stroke or transient ischemic attack
- Congestive heart failure New York Heart Association class ≥ II
- Pregnant or breast-feeding women
- Patients with reproductive potential not implementing accepted and effective means of contraception
- Participation in any other clinical trial within the previous 4 weeks
- Unable to comply with study procedures (e.g., claustrophobia, low back pain not allowing the patient to lay down in the examination bed)
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06147362
Start Date
June 1 2022
End Date
December 31 2023
Last Update
November 27 2023
Active Locations (1)
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1
Karolinska University Hospital
Stockholm, Sweden, 17176