Biodistribution/Reproducibility Ga-68 PSMA-HBED-CC

NCT02952469 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 201605762
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this Radioactive Drug Research Committee (RDRC) study is to collect initial data regarding biodistribution, reproducibility, and dosimetry for the radiotracer Ga-68 PSMA-HBED-CC, an agent which may be useful for the early detection of metastatic prostate cancer. Investigators will use a test and re-test design in all patients to determine reproducibility of lesion detection and signal intensity, and will include dynamic imaging in some patients for the purposes of dosimetry. Patients with known metastatic prostate cancer will be recruited and imaged on two occasions within the course of 15 days.

Conditions

Prostatic Neoplasms

Keywords

Positron-Emission Tomography; (68Ga)Glu-urea-Lys(Ahx)-HBED-CC; (68Ga)PSMA-HBED-CC; Glu-NH-CO-NH-Lys-(Ahx)-((68)Ga(HBED-CC)); (68)Ga-PSMA; 68Ga-PSMA-11

Outcome Measures

Primary Outcomes (1)

• Reproducibility assessment

  A second PET imaging assessment will be performed (test/retest) to confirm

  up to 15 days from first imaging

Secondary Outcomes (1)

• Biodistribution assessment

  60 minutes post-injection

Study Arms (1)

(68Ga)PSMA-HBED-CC

EXPERIMENTAL

Intervention: positron emission tomography / computed tomography (PET/CT) scan using a experimental radiotracer for imaging prostate-specific membrane antigen

Drug: (68Ga)PSMA-HBED-CC

Interventions

(68Ga)PSMA-HBED-CC DRUG

Experimental radiotracer for imaging prostate cancer

Also known as: (68Ga)Glu-urea-Lys(Ahx)-HBED-CC

(68Ga)PSMA-HBED-CC

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Male
• Aged ≥ 18 years
• Histological diagnosis of adenocarcinoma of the prostate OR have a clinical diagnosis of prostate cancer and on active therapy or have received treatment for prostate cancer.
• Multifocal metastatic disease in either castrate sensitive or castrate resistant patients.
• May or may not be on hormonal therapy, chemotherapy, or radium therapy.
• If on hormonal therapy or chemotherapy, must be on it for at least 3 months.
• No plans to undergo prostate cancer therapy administration (with hormone therapy, chemotherapy, radium therapy, external radiation) between the two study exams.
• At least 2 metastatic soft tissue or bone lesions identified on conventional imaging (CT, MRI or bone scan).
• Karnofsky performance status of ≥ 50 (or ECOG/WHO equivalent)
• Ability to understand and willingness to sign a consent document.
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection requiring hospitalization, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Physical limitation that would limit compliance with the study requirements
• Current enrollment in a therapeutic clinical trial

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

Location

Related Publications (2)

• Afshar-Oromieh A, Avtzi E, Giesel FL, Holland-Letz T, Linhart HG, Eder M, Eisenhut M, Boxler S, Hadaschik BA, Kratochwil C, Weichert W, Kopka K, Debus J, Haberkorn U. The diagnostic value of PET/CT imaging with the (68)Ga-labelled PSMA ligand HBED-CC in the diagnosis of recurrent prostate cancer. Eur J Nucl Med Mol Imaging. 2015 Feb;42(2):197-209. doi: 10.1007/s00259-014-2949-6. Epub 2014 Nov 20.

  PMID: 25411132 BACKGROUND

• Jilg CA, Drendel V, Rischke HC, Beck T, Vach W, Schaal K, Wetterauer U, Schultze-Seemann W, Meyer PT. Diagnostic Accuracy of Ga-68-HBED-CC-PSMA-Ligand-PET/CT before Salvage Lymph Node Dissection for Recurrent Prostate Cancer. Theranostics. 2017 Apr 10;7(6):1770-1780. doi: 10.7150/thno.18421. eCollection 2017.

  PMID: 28529650 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Janet Pollard, M.D.

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2016
• First Posted: November 2, 2016
• Study Start: July 14, 2016
• Primary Completion: April 25, 2022
• Study Completion: April 25, 2022
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)