Evaluation of Multiparametric Magnetic Resonance Imaging and Positron Emission Tomography with a [68Ga]gallium-labelled prostate-specific membrane antigen (PSMA) ligand for the Detection of Multiple Cancer Foci in Localized Prostate Cancer Patients – A Pilot Study
Queensland University of Technology
20 participants
Aug 1, 2014
Interventional
Conditions
Summary
The study aims to evaluate the applicability of Multiparametric Magnetic Resonance Imaging (MP MRI) and Positron Emission Tomography (PET) with [68Ga]Gallium-labelled prostate-specific membrane antigen (PSMA) ligand (68Ga-HBED-CC) for the detection of cancer foci in localised prostate cancer patients. You may be eligible to join this study if you are a male aged 18 years or above who has been diagnosed with localised prostate cancer, and are awaiting prostatectomy. All participants in this study will undergo Multiparametric (MP) Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET) with [68Ga]Gallium-labelled Prostate-specific membrane antigen ligand (68Ga-HBED-CC) and whole-mount pathology analysis. For MP MRI the participants will be lying flat on the back on a bed that moves through a scanner. In order to get the best pictures, the participants will be injected with a contrast agent (or “dye”). The whole scan would take about 30 to 40 minutes. A medication called Buscopan or Glucagon is injected into the blood stream to slow bowel movement, since a moving bowel can reduce the quality of the image. For PET, the [68Ga]Gallium-labelled Prostate-specific membrane antigen (PSMA) ligand will be injected into the blood stream. After 90 minutes, the participants will be placed in the PET scanner and the scan will begin (scanning takes ~30 minutes). A low dose whole-body computed tomography (CT) scan will be performed during the PET scan as this helps to interpret the PET scan. For whole-mount pathology, the participants do not need to do anything. The prostate tissue will be collected after surgery as part of their clinical management. A standard pathology report will be reported to the surgeon as a standard clinical management. Results will be compared and analysed once we have the results from PET scan, multiparametric MRI scan and wholemount pathology review.
Eligibility
Inclusion Criteria4
- Male patients pathologically diagnosed with localized prostate cancer, awaiting prostatectomy
- The time interval between last prostate biopsy and planned MP-MRI or planned 68Ga- HBED-CC PET must be not less than 8 weeks
- No known problems with peripheral intravenous or central line access
- Able to provide informed signed consent
Exclusion Criteria14
- Age under 18 years
- Prior pelvic external beam radiation therapy or brachytherapy, prior chemotherapy, prior hormonal or radiation therapy for prostate cancer
- Administered a radioisotope within 5 physical half-lives prior to study enrolment
- Treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration
- Hemorrhagic cystitis or active prostatitis
- Unable to lie flat during or unable to tolerate MP MRI or PET
- Prior history of any other malignancy within last 2 years
- Contraindication to MRI or MRI contrast agent or PET scan or [68Ga]gallium-labelled PSMA ligand
- Claustrophobia not manageable by oral sedatives ie Temazepam
- Moderate to severe rectal inflammation
- Previous rectal surgery that will affect prostate imaging
- MRI incompatible pacemakers
- Metallic implants or pumps which are MRI incompatible
- Renal impairment or hemodialysis.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
[68Ga]Gallium-labelled prostate specific membrane antigen HBED-CC ligand Glu-NH-CO-NH-Lys-(Ahx)-[68Ga-N,N'-bis [2-hydroxy-5-(carboxyethyl)benzyl] ethylenediamine-N,N'- diacetic acid] The dosage form is intravenous (IV) solution. The strength is 150MBq/5 micrograms. The infusion will last 5 minutes and 1 infusion is required. For MP MRI, the participants will be injected with a contrast agent (or “dye”). The whole scan would take about 30 to 40 minutes. A medication called Buscopan or Glucagon is injected into the blood stream to slow bowel movement, since a moving bowel can reduce the quality of the image. This scan will be undertaken once in the study. For PET, the [68Ga]Gallium-labelled Prostate-specific membrane antigen ligand PSMA ligand will be injected into the blood stream. After 90 minutes, the participants will be placed in the PET scanner and the scan will begin (scanning takes ~30 minutes). A low dose whole-body computed tomography (CT) scan will be performed during the PET scan as this helps to interpret the PET scan. This scan will be undertaken once in the study. For whole-mount pathology analysis, participants do not need to do anything. The prostate tissue will be collected after surgery as part of their clinical managements. In addition to a standard pathology report to the surgeon, specific pathology reports will be reported to the study team for analysis.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12614000783628