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A Phase 2 Assessment of the Diagnostic Accuracy of 99mTc-MIP-1404 Imaging in Men With High-Risk Prostate Cancer Scheduled for Radical Prostatectomy (RP) and Extended Pelvic Lymph Node Dissection (EPLND) Compared to Histopathology


Phase 2
21 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

A Phase 2 Assessment of the Diagnostic Accuracy of 99mTc-MIP-1404 Imaging in Men With High-Risk Prostate Cancer Scheduled for Radical Prostatectomy (RP) and Extended Pelvic Lymph Node Dissection (EPLND) Compared to Histopathology


Inclusion Criteria:



- Male aged 21 years or older.

- Ability to provide signed informed consent and willingness to comply with protocol
requirements.

- Biopsy confirmed presence of adenocarcinoma of the prostate gland.

- At high-risk for metastatic disease by a stage of cT3, cT4, or a total nomogram score
of greater than or equal to 130.

- Scheduled to undergo radical prostatectomy with extended pelvic lymph node
dissection.

- Agree to use an acceptable form of birth control for a period of 7 days after the
99mTc MIP-1404 injection.

Exclusion Criteria:

- Participating would significantly delay the scheduled standard of care therapy.

- Administered a radioisotope within 5 physical half lives prior to study drug
injection.

- Have any medical condition or other circumstances that, in the opinion of the
investigator, would significantly decrease obtaining reliable data, achieving study
objectives or completing the study.

- Have a contraindication for MR imaging.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Ability of 99mTc-MIP-1404 to detect prostate cancer within the prostate gland.

Outcome Description:

Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate and pelvic lymph nodes(as determined by histopathology) in patients undergoing standard of care prostatectomy with extended pelvic lymph node dissection. Pathology results will be used as the truth standard for all imaging analyses.

Outcome Time Frame:

Within 3-6 hours of dosing SPECT/CT images will be taken

Safety Issue:

No

Principal Investigator

Douglas Scherr, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

New York Presbyterian Hospital - Cornell

Authority:

United States: Food and Drug Administration

Study ID:

MIP-1404-201

NCT ID:

NCT01667536

Start Date:

August 2012

Completion Date:

December 2013

Related Keywords:

  • Prostate Cancer
  • PROSTATE CANCER
  • HIGH-RISK
  • PROSTATECTOMY SURGERY
  • NEWLY DIAGNOSED
  • Prostatic Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905
Medical University of South CarolinaCharleston, South Carolina  29425-0721
University of Washington School of MedicineSeattle, Washington  98195
Duke University Medical CenterDurham, North Carolina  27710
City of Hope National Cancer CenterDuarte, California  91010
University of WisconsinMadison,, Wisconsin  53792-5666
New York Presbyterian Hospital - CornellNew York City, New York  10021
Glickman Urology & Kidney Institute, Cleveland ClinicCleveland, Ohio  44195
Thomas Jefferson University / Jefferson Urology AssociatesPhiladelphia, Pennsylvania  19107
University of Texas Vanguard Urologic Research FoundationHouston, Texas  77030