Investigating a new imaging agent for prostate cancer using PET/CT
68Ga-NOTA-PEG2-RM26 PET/CT: Tracer Biodistribution and Uptake in Different Kinds of Cancer With Gastrin-Releasing Peptide Receptor (GRPR) Overexpression
This study is testing a new imaging agent to see if it can help doctors better detect prostate cancer using PET/CT scans.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska University Hospital Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT06147362 on ClinicalTrials.gov |
What this trial studies
This open-label study evaluates the diagnostic performance of 68Ga-NOTA-PEG2-RM26 in patients with prostate cancer. Participants will receive a single intravenous dose of the imaging agent, and the resulting PET/CT images will be assessed using visual and semiquantitative methods. The study aims to determine the safety, dosimetry, and clinical diagnostic value of this novel agent in detecting cancerous tissues. The gastrin-releasing peptide receptor, which is over-expressed in various tumors, is targeted by this new imaging compound.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with primary or recurrent prostate cancer or other specified cancers and adequate organ function.
Not a fit: Patients under 18 years old or those with significant cardiovascular issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of cancer diagnosis and improve treatment planning for patients.
How similar studies have performed: Other studies targeting gastrin-releasing peptide receptors have shown promise, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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)
Where this trial is running
Stockholm
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Jeffrey Yachnin, MD, PhD — Karolinska University Hospital
- Study coordinator: Antonios Tzortzakakis, MD, PhD
- Email: antonios.tzortzakakis@regionstockholm.se
- Phone: 08-123 70 000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.