A Pilot Study of 123I-MIP-1072 SPECT/CT Imaging With Optional Compact Gamma Camera Probe Imaging in Men With Prostate Cancer Undergoing Prostatectomy

This study has been terminated.
(Similar study to be completd once kit for new formulation becomes available.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Molecular Insight Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01279785
First received: January 18, 2011
Last updated: October 7, 2011
Last verified: October 2011
  Purpose

This is a single arm, open label study of up to 20 patients with prostate cancer scheduled for prostatectomy at the NIH Clinical Center. 123I-MIP-1072 image data will be evaluated for visible uptake and compared with histopathology.


Condition Intervention
Prostate Cancer
Drug: 123I-MIP-1072

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Phase 1 Pilot Study of 123I-MIP-1072 Single Photon Emission Computed Tomography (SPECT)/CT Imaging With Optional Compact Gamma Camera Probe Imaging in Men With Prostate Cancer Undergoing Prostatectomy

Resource links provided by NLM:


Further study details as provided by Molecular Insight Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • To evaluate the tissue distribution of 123I-MIP-1072 SPEC/CT imaging in tumor and non-tumorous regions of the prostate (as determined by histopathology) in patients undergoing standard of care prostatectomy [ Time Frame: Evaulated through Day 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the potential of 123I-MIP-1072 imaging to predict malignancy as defined by histopathology and multiparametric 3T MR [ Time Frame: Evaulated through Day 30 ] [ Designated as safety issue: No ]
  • To further evaluate the safety of 123I-MIP-1072 [ Time Frame: Evaluated through Day 30 ] [ Designated as safety issue: Yes ]
  • To evaluate the intensity of 123I-MIP-1072 uptake with respect to Gleason Grade [ Time Frame: Evaluated through Day 30 ] [ Designated as safety issue: No ]
  • To evaluate the intensity of 123I-MIP-1072 uptake with respect to PSMA expression [ Time Frame: Evaluated through Day 30 ] [ Designated as safety issue: No ]
  • To evaluate feasibility of imaging123I-MIP-1072 uptake using an FDA-approved compact endorectal gamma camera probe (CGCP) [ Time Frame: Evaluated through Day 30 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2011
Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Prostate Cancer Patients
Male participants who are scheduled to undergo standard of care prostatectomy for presumed localized prostate cancer at the NIH Clinical Center and have evidence of a recent (within 12 months of study entry) trans-rectal biopsy documenting adenocarcinoma of the prostate.
Drug: 123I-MIP-1072
Single IV dose
Other Name: Trofex

Detailed Description:

This is an exploratory, single arm, open label pilot study evaluation of 123I-MIP-1072 intraprostatic uptake determination by SPECT/CT imaging (and optional CGCP imaging), with histological confirmation of disease localization and staging. Methodical evaluation of 123I-MIP-1072 in intraprostatic tumorous and non-tumours regions will provide important preliminary data upon which further clinical studies can be based. The optional additional CGCP imaging was added, because of its inherent potential for higher resolution scintigraphic detection of 123I-MIP-1072 localization. This imaging feasibility data will provide important preliminary information for the use of CGCP imaging in prostate cancer.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Up to twenty adult men with biopsy confirmed prostate cancer scheduled for prostatectomy at the NIH Clinical Center will undergo 123I-MIP-1072 SPECT/CT and optional CGCP imaging prior to prostatectomy. These patients will also have undergone/will undergo multi-parametric 3T MR imaging at NIH which is considered standard of care at NIH clinical center.

Criteria

Inclusion Criteria:

  • Participant must be scheduled to undergo standard of care prostatectomy for presumed localized prostate cancer at the NIH Clinical Center.
  • Have had or will undergo multiparametric endorectal coil 3T MR at the NIH clinical center
  • Recent (within 12 months of study entry) trans-rectal biopsy indicating the presence of adenocarcinoma of the prostate gland
  • Participant must be 18 years or older.
  • ECOG Performance grade of 0 to 2. (see Appendix 1)
  • Ability to understand and provide informed consent. All subjects must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.
  • Participants of childbearing potential must agree to use an acceptable form of birth control, defined as abstinence, barrier or other acceptable, effective contraceptive method until 7 days after the infusion of study drug.

Exclusion Criteria:

  • Participants for whom participating would significantly delay the scheduled standard of care therapy.
  • Subjects must not have prostate biopsies performed within 12 weeks before imaging; or within 8 weeks before imaging providing that the absence of hemorrhage is confirmed by MR imaging.
  • SGOT and SGPT ≥ 2 x of the upper limits of normal; total bilirubin, of ≥ 1.5 x the upper limits of normal or ≥ 3.0 mg/dl in patients with Gilbert's syndrome.
  • Administered a radioisotope within 5 physical half lives prior to study enrollment.
  • Patients with severe claustrophobia unresponsive to oral anxiolytics
  • Subjects weighing ≥350 lbs or are unable to fit within the imaging gantry
  • Subjects who have received androgen deprivation therapy.
  • Subjects with 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01279785

Locations
United States, Maryland
CCR/NCI - Molecular Imaging Program
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Molecular Insight Pharmaceuticals, Inc.
Investigators
Principal Investigator: Peter Choyke, MD National Cancer Institute (NCI)
  More Information

No publications provided

Responsible Party: Molecular Insight Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01279785     History of Changes
Other Study ID Numbers: TX-P104
Study First Received: January 18, 2011
Last Updated: October 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Molecular Insight Pharmaceuticals, Inc.:
Molecular Imaging
PSMA
adenocarcinoma
prostatectomy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on October 19, 2014