99mTc-MIP-1404 for Imaging Prostate Cancer: Phase I Clinical Study to Assess the Image Quality of a Simplified Kit Formulation Compared to a Multi-step Preparation of 99mTc-MIP-1404
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2012 |
This trial is a single-blind, cross-over design. Up to three patients with confirmed
metastatic prostate adenocarcinoma and up to three healthy volunteers will receive two doses
of 20.0 (± 3) mCi of intravenously administered 99mTc MIP 1404 (preparation A or preparation
B). Whole-body planar scintigraphic images will be acquired at various time points on the
day of study drug administration. A pelvic SPECT/CT image will be acquired on the day of
study drug administration. Blood will be collected for pharmacokinetic measurements
following study drug administration. Each participant will receive an initial study drug
administration (preparation A) and a second study drug administration (preparation B)
approximately 7 to 21 days later. A final follow-up visit will occur approximately 2 - 3
weeks after the second study drug administration.
metastatic prostate adenocarcinoma and up to three healthy volunteers will receive two doses
of 20.0 (± 3) mCi of intravenously administered 99mTc MIP 1404 (preparation A or preparation
B). Whole-body planar scintigraphic images will be acquired at various time points on the
day of study drug administration. A pelvic SPECT/CT image will be acquired on the day of
study drug administration. Blood will be collected for pharmacokinetic measurements
following study drug administration. Each participant will receive an initial study drug
administration (preparation A) and a second study drug administration (preparation B)
approximately 7 to 21 days later. A final follow-up visit will occur approximately 2 - 3
weeks after the second study drug administration.
Inclusion Criteria:
- Male aged 21 years or older.
- Ability to provide signed informed consent and willingness to comply with protocol
requirements.
- Participants must agree to use an acceptable form of birth control throughout the
study period. Participants must agree to use condoms for a period of seven days after
each study drug administration, if engaged in sexual activity.
Additional Inclusion Criteria for Metastatic Prostate Adenocarcinoma Patients:
- Histologic diagnosis of prostate cancer by validated medical history (pathology
report, if available).
- Evidence of metastatic disease demonstrated by a documented abnormal bone scan, CT
scan, or MRI
- Karnofsky performance is ≥ 60
Additional Inclusion Criteria for Healthy Volunteers:
- PSA laboratory assessment within normal range (PSA < 4 ng/ml)
- Normal findings on a digital rectal examination
- Hemoglobin and hematocrit within normal range
Exclusion Criteria:
- Received a radioisotope within 5 physical half lives of that radioisotope prior to
study enrollment
- 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
- Participant is determined by the Investigator to be clinically unsuitable for the
study
- Serum creatinine ≥ 2.0 mg/dl
- Total bilirubin ≥ 2.0 mg/dl
- Liver transaminases ≥ 1.5 x ULN
- Platelet count < 100,000/mm3
- Absolute neutrophil count (ANC) < 2,000/mm3
- Hematocrit < 30% or hemoglobin < 10 g/dl
Additional Exclusion Criteria for Metastatic Prostate Adenocarcinoma Patients:
- Have received a permanent prostate brachytherapy implant within the last 3 months for
103Pd implants; or 12 months for 125I implants
- Have had any other malignancies within the past year, other than basal or squamous
cell carcinoma of the skin, in which the diagnosis and location have not been defined
as clinically controlled or treated to complete response
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