C-arm Cone-beam CT in Prostate Brachytherapy

NCT02322931 | Unknown

• 1 other identifier: H14-02658
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Dosimetric accuracy

  To determine if the intraoperative use of 3D C-arm cone-beam CT can eliminate the need for D-0 Ct for post-implant dosimetry in prostate LDR brachytherapy by providing similar or improved dosimetric accuracy

  12 months

Secondary Outcomes (2)

• Dosimetric values

  12 months

• Seed and boundary detection

  12 months

Study Arms (1)

Imaging interventions

EXPERIMENTAL

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.

Procedure: Intra-operative C-arm CT imaging

Interventions

Intra-operative C-arm CT imaging PROCEDURE

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).

Imaging interventions

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

RECRUITING

Related Publications (12)

• Blasko JC, Mate T, Sylvester JE, Grimm PD, Cavanagh W. Brachytherapy for carcinoma of the prostate: techniques, patient selection, and clinical outcomes. Semin Radiat Oncol. 2002 Jan;12(1):81-94. doi: 10.1053/srao.2002.28667.

  PMID: 11813153 BACKGROUND

• Chng N, Spadinger I, Morris WJ, Usmani N, Salcudean S. Prostate brachytherapy postimplant dosimetry: automatic plan reconstruction of stranded implants. Med Phys. 2011 Jan;38(1):327-42. doi: 10.1118/1.3525839.

  PMID: 21361201 BACKGROUND

• Dubois DF, Prestidge BR, Hotchkiss LA, Prete JJ, Bice WS Jr. Intraobserver and interobserver variability of MR imaging- and CT-derived prostate volumes after transperineal interstitial permanent prostate brachytherapy. Radiology. 1998 Jun;207(3):785-9. doi: 10.1148/radiology.207.3.9609905.

  PMID: 9609905 BACKGROUND

• Mahdavi SS, Chng N, Spadinger I, Morris WJ, Salcudean SE. Semi-automatic segmentation for prostate interventions. Med Image Anal. 2011 Apr;15(2):226-37. doi: 10.1016/j.media.2010.10.002. Epub 2010 Oct 26.

  PMID: 21084216 BACKGROUND

• Mahdavi SS, Spadinger I, Chng N, Salcudean SE, Morris WJ. Semiautomatic segmentation for prostate brachytherapy: dosimetric evaluation. Brachytherapy. 2013 Jan-Feb;12(1):65-76. doi: 10.1016/j.brachy.2011.07.007. Epub 2011 Sep 25.

  PMID: 21944824 BACKGROUND

• Moradi M, Mahdavi SS, Dehghan E, Lobo JR, Deshmukh S, Morris WJ, Fichtinger G, Salcudean ST. Seed localization in ultrasound and registration to C-arm fluoroscopy using matched needle tracks for prostate brachytherapy. IEEE Trans Biomed Eng. 2012 Sep;59(9):2558-67. doi: 10.1109/TBME.2012.2206808. Epub 2012 Jun 29.

  PMID: 22759435 BACKGROUND

• Morris WJ, Keyes M, Spadinger I, Kwan W, Liu M, McKenzie M, Pai H, Pickles T, Tyldesley S. Population-based 10-year oncologic outcomes after low-dose-rate brachytherapy for low-risk and intermediate-risk prostate cancer. Cancer. 2013 Apr 15;119(8):1537-46. doi: 10.1002/cncr.27911. Epub 2012 Dec 26.

  PMID: 23280183 BACKGROUND

• Narayana V, Roberson PL, Pu AT, Sandler H, Winfield RH, McLaughlin PW. Impact of differences in ultrasound and computed tomography volumes on treatment planning of permanent prostate implants. Int J Radiat Oncol Biol Phys. 1997 Mar 15;37(5):1181-5. doi: 10.1016/s0360-3016(96)00618-9.

  PMID: 9169829 BACKGROUND

• Nath R, Bice WS, Butler WM, Chen Z, Meigooni AS, Narayana V, Rivard MJ, Yu Y; American Association of Physicists in Medicine. AAPM recommendations on dose prescription and reporting methods for permanent interstitial brachytherapy for prostate cancer: report of Task Group 137. Med Phys. 2009 Nov;36(11):5310-22. doi: 10.1118/1.3246613.

  PMID: 19994539 BACKGROUND

• Roach M 3rd, Faillace-Akazawa P, Malfatti C, Holland J, Hricak H. Prostate volumes defined by magnetic resonance imaging and computerized tomographic scans for three-dimensional conformal radiotherapy. Int J Radiat Oncol Biol Phys. 1996 Jul 15;35(5):1011-8. doi: 10.1016/0360-3016(96)00232-5.

  PMID: 8751410 BACKGROUND

• Smith WL, Lewis C, Bauman G, Rodrigues G, D'Souza D, Ash R, Ho D, Venkatesan V, Downey D, Fenster A. Prostate volume contouring: a 3D analysis of segmentation using 3DTRUS, CT, and MR. Int J Radiat Oncol Biol Phys. 2007 Mar 15;67(4):1238-47. doi: 10.1016/j.ijrobp.2006.11.027.

  PMID: 17336224 BACKGROUND

• Bice WS Jr, Prestidge BR, Grimm PD, Friedland JL, Feygelman V, Roach M 3rd, Prete JJ, Dubois DF, Blasko JC. Centralized multiinstitutional postimplant analysis for interstitial prostate brachytherapy. Int J Radiat Oncol Biol Phys. 1998 Jul 1;41(4):921-7. doi: 10.1016/s0360-3016(98)90123-7.

  PMID: 9652858 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

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

• William J Morris, MD

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenz Yeung

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2014
• First Posted: December 23, 2014
• Study Start: January 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 18, 2018

Record last verified: 2018-01

Locations

CA (1)