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Multifunctional Magnetic Resonance (MR) for Radiotherapy Planning in Prostate Cancer

Information source: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: Imaging Investigations (not radiation) (Other); Other (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Royal Marsden NHS Foundation Trust

Official(s) and/or principal investigator(s):
Dr Nandita deSouza, Principal Investigator, Affiliation: CRUK Clinical Magnetic Resonance Research Group

Overall contact:
Dr Nandita deSouza, Phone: 02086613289, Email: nandita.desouza@icr.ac.uk

Summary

To determine if functional MRI methods will aid planning of a radiation dose boost within the prostate in patients with prostate cancer potentially improving safety and efficacy.

Clinical Details

Official title: Multifunctional MR for Radiotherapy Planning in Prostate Cancer

Study design: Intervention Model: Single Group Assignment, Primary Purpose: Diagnostic

Primary outcome: Comparison of dose distributions produced by rival radiotherapy plans judged using radiobiological model predictions of Tumour Control Probability (TCP) and Normal Tissue Complication Probability (NTCP).

Secondary outcome:

Comparison of reproducibility of registration algorithms for mapping functional MR data acquired before hormone therapy to MR anatomical data acquired after hormone therapy and prior to radiotherapy.

Comparison of reproducibility of registration of functional and MR data with computed tomography (CT) data using gold seed registration, assessing reproducibility and positioning issues.

Comparison of image quality, registration reproducibility and gland distortion of internal and external imaging coils for MRI image acquisition and registration of the prostate.

Comparison of dose distributions produced by rival radiotherapy plans judged using three standard dose-volume constraints for targets and normal tissues and careful examination of the 3D dose distribution.

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Hormone therapy naive patients planned to be treated by radical radiotherapy after

3-6 months of androgen suppression

- Patients with low-high risk histologically confirmed localised disease are eligible,

with WHO performance status 0-1. Exclusion Criteria:

- Patients unsuitable for functional MRI of the prostate or gold seed fiducial marker

insertion (e. g. patients unable to tolerate endorectal MRI examination).

- No prior pelvic radiotherapy or radical prostatectomy, previous androgen therapy,

patients unsuitable for radical radiotherapy, life expectancy <10 years, previous active malignancy within last 5 years, co-morbid conditions likely to impact on the advisability of radical radiotherapy, full anticoagulation, other exclusions to MRI (e. g. hip prosthesis or fixation, claustrophobia, ferromagnetic implants).

Locations and Contacts

Dr Nandita deSouza, Phone: 02086613289, Email: nandita.desouza@icr.ac.uk

Royal Marsden NHS Foundation Trust, Sutton, Surrey SM2 5PT, United Kingdom; Recruiting
Additional Information

Starting date: March 2009
Last updated: November 2, 2009

Page last updated: August 23, 2015

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