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68Ga-PSMA PET-CT Scan for Diagnosis and Management of Prostate Cancer (PSMA)

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ClinicalTrials.gov Identifier: NCT02282137
Recruitment Status : Unknown
Verified April 2015 by Ebrahim Delpassand, Radio Isotope Therapy of America.
Recruitment status was:  Recruiting
First Posted : November 4, 2014
Last Update Posted : April 14, 2015
Sponsor:
Collaborators:
Radiomedix, Inc.
Excel Diagnostics and Nuclear Oncology Center
Information provided by (Responsible Party):
Ebrahim Delpassand, Radio Isotope Therapy of America

Brief Summary:
Single center, Prospective, Phase II expanded access clinical studies of 68Ga-PSMA (ProstaMedix TM) used for diagnosis and management of patients with prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: 68Ga-PSMA Phase 2

Detailed Description:
The goal of this trial is to evaluate patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging (MRI). 68Ga-PSMA PET/CT imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. Suspected prostate recurrence will be based upon elevated blood prostate specific antigen (PSA) levels following initial therapy.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 68Ga-PSMA (ProstaMedix™) PET-CT Scan for Diagnosis and Management of Prostate Cancer
Study Start Date : April 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 68Ga-PSMA
Evaluation of concordance and discordance between the results of 68Ga-PSMA PET/CT and other available conventional imaging modalities (such as CT, MRI, FDG, NaF scan), histology or follow up.
Drug: 68Ga-PSMA
Patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging (MRI). Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy.
Other Name: 68Ga-HBED-CC-PSMA




Primary Outcome Measures :
  1. The evidence of suspected or clinically confirmed prostate cancer confirmed by 68Ga-PSMA PET/CT. [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent.
  • Male patients, aged 18 years.
  • Histologically and/or clinically confirmed and/or suspicious of Prostate cancer.
  • Recent Blood test results up to 4.6 weeks as follows: WBC: >2*109/L, Haemoglobin: >8.0g/Dl, Platelets: >50x109/L

Exclusion Criteria:

  • Known hypersensitivity to 68Ga, HBED-CC, PSMA or to any of the excipients of 68Ga-PSMA.
  • Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02282137


Contacts
Contact: Tannaz Armaghany, MD 713-523-6700 tarm@westcca.com

Locations
United States, Texas
Radio- Isotope Therapy of America Recruiting
Houston, Texas, United States, 77042
Contact: Ebrahim S Delpassand, MD         
Principal Investigator: Ebrahim S Delpassand, MD         
Radio-Isotope Therapy of America Recruiting
Houston, Texas, United States, 77042
Contact: Gelareh Vahdati       gvahdati@exceldiagnostics.com   
RITA Foundation Recruiting
Houston, Texas, United States, 77042
Contact: Susan Cork    713-341-3203    scork@exceldiagnostics.com   
Contact: Izabela Tworowska, PhD    8328682812    itworowska@radiomedix.com   
Principal Investigator: Tannaz Armaghany, MD         
Sponsors and Collaborators
Ebrahim Delpassand
Radiomedix, Inc.
Excel Diagnostics and Nuclear Oncology Center
Investigators
Study Director: Ebrahim S Delpassand, MD RITA Foundation

Responsible Party: Ebrahim Delpassand, Chairman and Medical Director, Radio Isotope Therapy of America
ClinicalTrials.gov Identifier: NCT02282137     History of Changes
Other Study ID Numbers: Ga PSMA124388
IND124388 ( Other Identifier: US Food and Drug Administration )
First Posted: November 4, 2014    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: April 2015

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