Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Molecular Insight Pharmaceuticals, Inc.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Have a prior histological diagnosis of prostate cancer.
Have evidence of recurrent metastatic disease demonstrated by an abnormal bone scan, CT scan or MRI plus:
1. PSA\> 1.0 if patient is post prostatectomy or post ablative radiotherapy, or
2. PSA\> 20 if intact prostate
Have platelet count of \> 50,000/mm3
Have neutrophil count of \> 1,000/mm3
Provide written informed consent and willing to comply with protocol requirements
Greater than or equal to 18 years of age
Can be on hormonal therapy if dose stable for \> 90 days
You may not be if
Karnofsky performance status of \<60
Inadequate venous access (two antecubital or equivalent venous access sites are required for study drug injection and PK blood sampling, respectively)
Patient received a permanent prostate brachytherapy implant within the last 3 months (for Pd-103 implants) or 12 months (for I-125 implants).
Patient received external beam therapy or chemotherapy within the last 30 days
Administered a radioisotope within 5 physical half lives prior to study enrollment
Serum creatinine \> 3.5 mg/dL
Total bilirubin \> 2.5 times the upper limit of normal
Liver transaminases greater than 5x the upper limit of normal
Received an investigational compound and/or medical device or is part of an investigational study within the past 30 days before enrollment into this study
Have any medical condition or other circumstances which, in the opinion of the Investigator, would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow-up examinations
Is determined by the Investigator that the patient is clinically unsuitable for the study
Have had any other malignancies within 5 years other than basal or squamous cell carcinoma of the skin.
Clareo Health | Study to Evaluate the Safety, Pharmacokinetics, Tissue Distribution, Metabolism and Dosimetry of Two Prostate Cancer Imaging Agents
