Recruiting

C-arm Cone-beam CT

Sponsor:

British Columbia Cancer Agency

Code:

NCT02322931

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intra-operative C-arm CT imaging

Study Details

Brief summary:

The investigators will assess the feasibility of intraoperative use of C-arm cone-beam CT imaging for intraoperative dosimetric evaluation in prostate low-dose-rate (LDR) brachytherapy. Patients recruited are those who will receive standard LDR brachytherapy for prostate cancer treatment. Consenting patients will undergo additional 3D C-arm cone-beam CT imaging (3D C-arm) and motorized trans-rectal ultrasound (TRUS). Volumetric and dosimetric measures will be compared to those using the standard Day-0 CT images. The investigators hope that the intraoperative 3D C-arm provides quality assurance measures sufficient to eliminate the need for Day-0 CT LDR brachytherapy and provide the opportunity for intraoperative modification of seed delivery plan.

Conditions

Prostate Cancer

Study ID

NCT02322931

Start date

Jan, 2015

Status verified date

Jan, 2018

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Must be 18 years of age or older
  • Must be able to give informed consent
  • Must have been diagnosed with prostate cancer, as determined by a prostate biopsy
  • Must not have had any prior history of cancer. Participants that have had some types of skins cancer are still able to participate
  • Must be eligible for and receiving low-dose-rate prostate brachytherapy

Exclusion Criteria:

  • They are unable to undergo general or spinal anesthesia
  • They are on anticoagulation therapy (blood thinners)
  • They have had previous radiotherapy to the pelvis

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Imaging interventions

Eligible patients who consent to participate in this study will undergo a combination of 4 different imaging interventions (based on the group they're in, as described in the protocol), intra-operatively, in addition to their standard LDR brachytherapy treatment.

Interventions

Intra-operative C-arm CT imaging

1. Two intra-operative C-arm 3D reconstruction scans with the Ziehm Vision FD Vario 3D immediately after treatment implantation, once with the TRUS probe inserted and once with the TRUS probe removed. This involves approximately 10 fluoroscopy snapshots of the prostate.
2. Two TRUS Sagittal B-mode sweeps and two TRUS axial B-mode sweeps, once mid-way, i.e. after implanting a sub-set of the seeds, and once at the end of the implantation procedure.
3. One Cine loop C-arm scan in the sagittal plane while retracting the probe.
4. One 3D C-arm scan immediately after the treatment, with the TRUS probe removed and the patient in the supine position (i.e. legs down).

Primary outcome measure

  • Dosimetric accuracy [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Lorenz Yeung

604-87-6000Lorenz.Yeung@bccancer.bc.ca

Locations

British Columbia Cancer Agency

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Contacts

Sunshine Purificacion, MSc

604-877-6000sunshine.purificacion@bccancer.bc.ca

Principal Investigator:

William J Morris, MD

More Information

Sponsor

British Columbia Cancer Agency

Last update posted

Jan 18, 2018

Last verified

Jan, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by British Columbia Cancer Agency on 2018-01-18.