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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


Phase 1
21 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Outcome Measure:

To assess the image quality of a simplified kit formulation of 99mTc-MIP-1404 (study drug) compared to a multi-step preparation of 99mTc-MIP-1404 in patients with confirmed metastatic prostate adenocarcinoma and in healthy volunteers

Outcome Time Frame:

Whole-body planar scintigraphic images will be acquired at 30 min, 2 and 4 hours post administration. A pelvic SPECT/CT image will be acquired at 3 hours post study drug administration

Safety Issue:

No

Principal Investigator

Stanley J Goldsmith, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Nuclear Medicine, New York Presbyterian Hospital, Weill Cornell Medical College

Authority:

United States: Food and Drug Administration

Study ID:

MIP-TcTx-P101b

NCT ID:

NCT01654874

Start Date:

July 2012

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

New York Presbyterian Hospital, Weill Cornell Medical CollegeNew York, New York  10065