Study of the use of MRI for radiation therapy treatment planning for patients with complex pelvic cancers

Not Applicable

Completed

• Conditions: Rectal Cancer; Anal Canal Cancer; Endometrial Cancer; Cervical Cancer; Cancer - Bowel - Anal; Cancer - Bowel - Back passage (rectum) or large bowel (colon); Cancer - Womb (Uterine or endometrial cancer); Cancer - Cervical (cervix)

• Registration Number: ACTRN12617001406392
• Lead Sponsor: aura O'Connor

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-04
• Study Completion: 2019-12-09
• Last Update Posted: 24 November 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. >18 years of age
2. Patient able to provide informed consent
3. Histological diagnosis of a malignancy of the rectum, anal canal, cervix or endometrium
4. To be treated definitively with radical Radiotherapy +/- concurrent chemotherapy +/- surgery
5. Suitable for IMRT or VMAT planning

Exclusion Criteria

1. ECOG performance status >1
2. Clinical evidence of distant metastatic disease
3. Women who are pregnant or lactating
4. Inability to have a MRI due to:
a. Implanted magnetic metal e.g. intraocular metal, aneurysm clip, or other metallic implant
b. Pacemaker/ implanted defibrillator
c. Extreme claustrophobia
5. Mental impairment/intellectual impairment in which the patient would have difficulty giving informed consent to the study
6. Bariatric patients (patients with a BMI > 30)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This is a composite primary outcome to demonstrate the mean dosimetric agreement and 95% confidence interval between conventional CT and synthetic CT for radiotherapy treatment planning of cancers of the rectum, anal canal, endometrium and cervix[after completion of radiotherapy treatment planning]

Secondary Outcome Measures

Name	Time	Method
To demonstrate the Hounsfield Unit comparison of conventional CT and synthetic CT for complex pelvic cancers using mean absolute error[after completion of radiotherapy treatment planning];To demonstrate the generation of digitally reconstructed radiographs (DRR’s) from synthetic CT for on treatment guidance. A mock image guidance alignment will be performed using synthetic CT DRR based alignment and cone-bean CT based alignment. The differences in these measurements compared to the gold standard CT will be quantified[after completion of radiotherapy treatment planning]