Novel Imaging in Staging of Primary Prostate Cancer

NACompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

March 1, 2018

Primary Completion Date

September 22, 2019

Study Completion Date

May 2, 2022

Conditions
High Risk Prostate Cancer
Interventions
DIAGNOSTIC_TEST

Whole body contrast enhanced computer tomography

Computed tomography of the thorax, abdomen and pelvis will be performed as a part of routine clinical evaluation protocol. The imaging will be done with contrast agent if there are no clinical contraindications for the use of contrast agent.

DIAGNOSTIC_TEST

99mTC-HMDP planar bone scintigraphy (BS)

Planar bone scintigraphy will be performed as a part of routine clinical evaluation protocol. The subjects will be positioned supine on a Discovery NM/CT 670 CZT, a digital SPECT/CT scanner (General Electric Healthcare). The scanner includes a dual-detector, free-geometry integrated nuclear imaging camera with the advanced digital CZT detector technology combined with the high-performance Optima CT540 subsystem. Whole-body planar images will be scanned from the anterior and posterior views three hours after the intravenous injection of 670 MBq of 99mTc-HMDP. A wide-energy high-resolution (WEHR) collimator, a scan speed of 13 cm/min, a zoom of 1.0 and a matrix size of 256 x 1024 are used in the scintigraphy.

DIAGNOSTIC_TEST

99mTc-HMDP single photon emission computer tomography/computer tomography

SPECT/CT imaging will be carried out after acquisition of the planar images with the same scanner. Three bed positions of SPECT data will be acquired from the top of the head to mid femoral level using WEHR collimators. A non-circular orbit, 60 views with 15-s scanning time per view will be acquired during 180 degrees of rotation. A 128 x 128 matrix size, a zoom of 1.0 and 15% photopeak and lower scatter energy windows are used. After SPECT a CT topogram and a low-dose tomogram with a modulated mAs (noise index \~ 70), 120 kVp, a pitch of 1.35 and a 2.5-mm slice thickness are scanned. The co-registration of SPECT and CT data is verified after which the SPECT images are reconstructed using modern iterative ordered subsets expectation (OSEM) reconstruction algorithm from General Electric or Hermes Medical Solutions, which includes, e.g., 10 iterations and 5 subsets and attenuation, collimator and scatter corrections.

DIAGNOSTIC_TEST

Whole-body magnetic resonance imaging

Magnetic resonance imaging examination will be performed using a 1.5T (Philips 1.5T Ingenia, Best, Netherlands and/or Siemens 1.5T Aera/Avant, Erlangen, Germany) or 3T (Philips 3T Ingenia, Best, Netherlands and/or Siemens 3T Skyra fit, Erlangen, German) MR system. The body matrix coil in combination with a spinal coil will be used for image acquisition. T1-weighted anatomic imaging, STIR fat suppressed images and DWI will be performed in axial and coronal directions. DWI will be obtained with single-shot 2D spin-echo echo-planar imaging. The total scan time will be approximately 50 minutes.

DIAGNOSTIC_TEST

Fluorine-18-prostate specific membrane antigen-1007- positron emission tomography/computer tomography

18F-PSMA-1007 is produced by radiolabelling with fluorine-18 produced by irradiating oxygen-18. Administration of the formulated solution is done shortly (\<10h) after production. Imaging is carried out with digital PET/CT scanner (Discovery MI;General Electric Medical Systems, Milwaukee, WI, USA). The patients receive intravenous injection of 200-300 MBq (3 MB/kg) of 18F-PSMA-1007 diluted in 3-5 ml of saline as a 60-sec bolus which will be promptly flushed with saline. Before data acquisition patients will be asked to void. A static emission scan will be acquired 60-min from tracer injection over whole body. The sinogram data will be corrected for deadtime, decay and photon attenuation and reconstructed in a 256x256 matrix. Image reconstruction follows a fully 3D maximum likelihood ordered subsets expectation maximization algorithm incorporating random and scatter correction with two iterations and 28 subsets.The final in-plane full-width half-maximum of the systems is \< 6 mm.

Trial Locations (1)

20521

Department of Urology, Turku

All Listed Sponsors
collaborator

University of Turku

OTHER

lead

Turku University Hospital

OTHER_GOV

NCT03537391 - Novel Imaging in Staging of Primary Prostate Cancer | Biotech Hunter | Biotech Hunter