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68Ga-DOTA-Bombesin PET/MRI in Imaging Patients With Prostate Cancer

Primary Purpose

Prostate Carcinoma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

68Ga-DOTA-Bombesin

Magnetic Resonance Imaging (MRI) scan

Positron Emission Tomography (PET) scan

About this trial

This is an interventional diagnostic trial for Prostate Carcinoma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

INCLUSION CRITERIA

Provides written informed consent
Known diagnosis of prostate cancer
Patient has suspected recurrence based on biochemical data [prostate-specific antigen (PSA) > 2 ng/mL]
Able to remain still for duration of each imaging procedure (about one hour)

EXCLUSION CRITERIA

Unable to provide informed consent
Inability to lie still for the entire imaging time
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
Metallic implants

Sites / Locations

Stanford University Hospitals and Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-DOTA-Bombesin PET/MRI

Arm Description

Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.

Outcomes

Primary Outcome Measures

Normal Biodistribution of 68Ga-DOTA-Bombesin

Radiopharmaceutical uptake in normal organs will be evaluated visually and measured semi-quantitatively using standardized uptake values (SUV) derived from the PET/CT scan software in patients with prostate cancer. Uptake values in different tissues will be measured as SUVmean (mean value for SUV). SUVmean values reflect relative uptake of the radiolabel into the tissue.

Secondary Outcome Measures

68Ga-DOTA-Bombesin Feasibility

Feasibility of 68Ga-DOTA-Bombesin as a radiopharmaceutical for PET/MRI was assessed as the percentage of enrolled subjects who complete the examination, and for which the PET/MRI data were evaluable.

Full Information

NCT ID

NCT02440308

First Posted

May 1, 2015

Last Updated

February 28, 2017

Sponsor

Stanford University

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT02440308

Brief Title

68Ga-DOTA-Bombesin PET/MRI in Imaging Patients With Prostate Cancer

Official Title

68Ga-DOTA-Bombesin PET/MRI in the Evaluation of Patients With Prostate Cancer: A Feasibility Study

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

April 2015 (undefined)

Primary Completion Date

June 30, 2015 (Actual)

Study Completion Date

June 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This clinical trial studies the use of gallium-68 (68Ga)-DOTA-Bombesin as the imaging agent for positron emission tomography (PET)/magnetic resonance imaging (MRI), collectively PET-MRI, in patients with prostate cancer. PET uses a radioactive substance called 68Ga-DOTA-Bombesin, which attaches to tumor cells with specific receptors on their surfaces. The PET scanner takes pictures that capture where the radioactive drug is "lighting up" and attaching to tumor cells, which may help doctors recognize differences between tumor and healthy prostate tissue. MRI uses radio waves and a magnet to make a picture of areas inside the body. Using 68Ga-DOTA-Bombesin in diagnostic procedures, such as PET/MRI, may allow doctors to identify smaller tumors than standard imaging.

Detailed Description

PRIMARY OBJECTIVES: I. To evaluate the feasibility and biodistribution of 68Ga-DOTA-Bombesin (BAY 86-7548 or 68Ga-DOTA RM2). OUTLINE: Patients receive 68Ga-DOTA-Bombesin intravenously (IV) and then undergo PET/MRI approximately 1 hour later. After completion of study, patients are followed up at 24 hours and 1 week.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Carcinoma

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

68Ga-DOTA-Bombesin PET/MRI

Arm Type

Experimental

Arm Description

Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.

Intervention Type

Drug

Intervention Name(s)

68Ga-DOTA-Bombesin

Other Intervention Name(s)

68Ga-DOTA RM2, BAY 86-7548, Gallium-68-labeled GRPr Antagonist

Intervention Description

68Ga-DOTA-Bombesin is a gallium-68-labeled gastrin-releasing peptide receptor (GRPr) antagonist. DOTA is [4,7,10-Tris-(carboxymethyl)-1,4,7,10-tetraazacyclododec-1-yl]-acetyl. 68Ga-DOTA-Bombesin is administered intravenously (IV)

Intervention Type

Procedure

Intervention Name(s)

Magnetic Resonance Imaging (MRI) scan

Other Intervention Name(s)

Nuclear Magnetic Resonance (NMR) scan

Intervention Type

Procedure

Intervention Name(s)

Positron Emission Tomography (PET) scan

Other Intervention Name(s)

Proton magnetic resonance spectroscopic imaging

Primary Outcome Measure Information:

Title

Normal Biodistribution of 68Ga-DOTA-Bombesin

Description

Time Frame

1 hour

Secondary Outcome Measure Information:

Title

68Ga-DOTA-Bombesin Feasibility

Description

Feasibility of 68Ga-DOTA-Bombesin as a radiopharmaceutical for PET/MRI was assessed as the percentage of enrolled subjects who complete the examination, and for which the PET/MRI data were evaluable.

Time Frame

Up to 1 week

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

INCLUSION CRITERIA Provides written informed consent Known diagnosis of prostate cancer Patient has suspected recurrence based on biochemical data [prostate-specific antigen (PSA) > 2 ng/mL] Able to remain still for duration of each imaging procedure (about one hour) EXCLUSION CRITERIA Unable to provide informed consent Inability to lie still for the entire imaging time Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.) Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance Metallic implants

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrei Iagaru

Organizational Affiliation

Stanford University Hospitals and Clinics

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University Hospitals and Clinics

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26659347

Citation

Minamimoto R, Hancock S, Schneider B, Chin FT, Jamali M, Loening A, Vasanawala S, Gambhir SS, Iagaru A. Pilot Comparison of (6)(8)Ga-RM2 PET and (6)(8)Ga-PSMA-11 PET in Patients with Biochemically Recurrent Prostate Cancer. J Nucl Med. 2016 Apr;57(4):557-62. doi: 10.2967/jnumed.115.168393. Epub 2015 Dec 10.

Results Reference

derived

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68Ga-DOTA-Bombesin PET/MRI in Imaging Patients With Prostate Cancer

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