Study on Optimizing Dose and Diagnostic Accuracy in Prostate Cancer Using Advanced Imaging Techniques
Sponsor: Lantheus Medical Imaging
ClinicalTrials ID:NCT07831824
This clinical trial is exploring a new imaging method to improve the detection and treatment planning for prostate cancer. The study involves two phases: optimizing the imaging dose and evaluating the accuracy of the imaging technique in detecting prostate cancer in patients who are at high risk or have suspected spread of the disease.
Patient Parameters
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Program Overview
This study aims to improve how prostate cancer is detected and treated by using a new imaging technique. It is divided into two parts. The first part focuses on finding the best dose and timing for the imaging process. The second part evaluates how well this imaging method can detect prostate cancer, especially in the pelvic lymph nodes, compared to traditional methods. Participants will undergo imaging and surgery to confirm the accuracy of the imaging results. Safety will be monitored throughout the study.
Description
The study is conducted in two phases. In Phase 2, participants will receive a specific dose of a radiotracer for PET/CT imaging to determine the best dose and timing for clear images. Up to 12 participants will have multiple scans to assess how the radiotracer spreads in the body and how well it highlights cancerous areas. This phase helps decide the optimal dose and timing for the next phase.
In Phase 3, the study will test how accurately the imaging method detects prostate cancer in the pelvic lymph nodes and other areas. Participants will undergo imaging using the optimized dose and timing from Phase 2. The accuracy of the imaging will be compared to the results from surgery and other tests. The study will also explore how this imaging method affects treatment decisions.
Throughout the study, safety will be closely monitored, including any side effects and changes in vital signs. The study aims to provide better imaging techniques for prostate cancer detection and treatment planning.
Eligibility Criteria
Inclusion Criteria
- Male participants aged 18 or older.
- Must agree to use effective contraception during the study and for 7 days after the last dose.
- Willing to take anti-anxiety medication if claustrophobic.
- Good overall health with specific blood and organ function levels.
- Confirmed diagnosis of prostate cancer and meet specific criteria for high-risk or recurrent cancer.
- Willing to comply with all study requirements and procedures.
Exclusion Criteria
- Recent use of certain radioactive or contrast agents.
- Recent or planned alternative treatments for prostate cancer.
- History of other cancers that may affect study results, except for certain treated cancers.
- Medical or psychological conditions that may interfere with the study.
- Participation in another clinical study.
- Known allergies to the study drug or its components.
- Significant heart disease or other serious health conditions.
- Unresolved side effects from previous treatments.
- Evidence of cancer spread that would prevent surgery.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| BAMF Health | 49503 | Grand Rapids | Michigan |
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