A Pilot Study Using Magnetic Resonance (MR) to Assess Cervix Motion During Radiotherapy Treatment.

NCT03101306 | Completed

• 1 other identifier: 17_RADIO_122
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The standard treatment for locally advanced cervical cancer is concurrent chemo-radiotherapy. This treatment is associated with long term side effects in around half of patients with up to 10% suffering from grade 3-4 toxicity. The development of intensity modulated radiotherapy (IMRT) allows for shaping of radiotherapy fields to reduce the doses delivered to organs at risk (OARs). This does appear to reduce the risk of long and short term toxicity (although there is little randomized evidence). However pelvic organ position varies both between and even during radiotherapy fractions; this means that radiotherapy margins must be generous to allow adequate coverage of the clinical target volume (CTV) but this also increases dose to OARs. There have been a number of studies evaluating pelvic organ motion in cervical cancer as well as assessing different adaptive radiotherapy strategies. These have included individualized margins, plan of the day and adaptive techniques. Most of these studies have been carried out using cone beam computed tomography (CBCT) imaging which is often poor quality with limited soft tissue contrast. MR offers better visualization of the tumour and OARs and is used for imaged guided brachytherapy treatment. This study will explore the role of MR imaging in adaptive radiotherapy for cervical cancer with development of a number of theoretical treatment strategies.

Conditions

Cervical Cancer

Keywords

cervix, radiotherapy, magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• Coverage of the Clinical Target Volume and dose to the Organs At Risk for different adaptive radiotherapy strategies.

  Coverage of the Clinical Target Volume and dose to the Organs At Risk for different adaptive radiotherapy strategies.

  18 months

Secondary Outcomes (2)

• Diffusion Weighted Imaging on MR prior to and during treatment and clinical response to treatment on post treatment MR scan.

  18 months

• Bladder filling using MR sequences and stratification of patients into large or small cervix motion.

  18 months

Study Arms (1)

MR scans

EXPERIMENTAL

As part of the study patients will undergo 3 additional MR scans during radiotherapy treatment. These will take place in the 1st, 2nd and 5th weeks of treatment.

Other: MR scans

Interventions

MR scans OTHER

Additional imaging using MR scans.

MR scans

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed diagnosis of cervical cancer
• Treatment with primary curative intent
• Undergoing external beam radiotherapy (+/-chemotherapy) followed by brachytherapy or an external beam boost
• Age over 18

You may not qualify if:

• Any contraindications to MR identified after MR safety screening including completion of an MR Safety Screening Form (see appendix 1)
• Previous hysterectomy
• Unable to tolerate MR scans
• Metastatic disease
• Pregnancy

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, Greater Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Marcel van Herk

  University of Manchester

  PRINCIPAL INVESTIGATOR

• Ananya Choudhury

  The Christie NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Project Manager on behalf of Dr Ananya Choudhury

Model Details: Single site, non-randomised basic science study.

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: April 5, 2017
• Study Start: September 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: August 2, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)