A study investigating whether hyoscine butylbromide improves image quality of computed tomography (CT) when giving stereotactic ablative radiotherapy (SABR) in the abdomen and pelvis

Not Applicable

Completed

• Conditions: imited areas of cancer in the lower abdomen and pelvis; Cancer

• Registration Number: ISRCTN24362767
• Lead Sponsor: niversity of Leeds

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34381954/ results (added 13/08/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-02
• Study Completion: 2021-01-11
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Aged 18 years or older
2. Capacity to give written, informed consent
3. WHO performance status 0-2
4. Histologically or radiologically confirmed lymph node or bone oligometastatic disease in the abdomen or pelvis limited to < = 3 lesions in total
5. All metastases must be visible on imaging and be suitable for stereotactic ablative radiotherapy in the lower abdomen and pelvis as per the NHS England Commissioning through Evaluation criteria or the Conventional care versus radioablation (stereotactic body radiotherapy) for extracranial oligometastases (CORE) study
6. Predicted life expectancy > 6 months
7. No co-morbid conditions likely to impact on the advisability of SABR (e.g. previous inflammatory bowel disease, previous abdominal or pelvic surgery, significant bladder instability or urinary incontinence, clinically significant renal or hepatic impairment)
8. No comorbidities likely to impact on safety of administration of HBB (for example severe cardiac disease, recent cardiac event, cardiac tachyarrhythmias, angle closure glaucoma, myasthenia gravis, pyloric stenosis, porphyria, severe ulcerative colitis, paralytic ileus, obstructive uropathy or allergy to HBB)
9. No bilateral prosthetic hips- this would prevent use of volumetric modulated arc therapy (VMAT) solution for SABR
10. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol; those conditions should be discussed with the patient before registration in the trial

Exclusion Criteria

No comorbidities likely to impact on safety of administration of HBB (for example severe cardiac disease, recent cardiac event, cardiac tachyarrythmias, angle closure glaucoma, myasthenia gravis, pyloric stenosis, porphyria, severe ulcerative colitis, paralytic ileus, obstructive uropathy or allergy to hyoscine butylbromide)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cone beam CT image quality when HBB administered, determined by proportion of images with improved Likert-type scale results at end of SABR treatment

Secondary Outcome Measures

Name	Time	Method
<br> 1. Feasibility of administration of intramuscular HBB within a clinical abdomino-pelvic SABR workflow, measured using questionnaire at time of final SABR fraction<br> 2. Patient and radiotherapy department staff acceptability of intramuscular HBB injection, assessed using questionnaire at time of final SABR fraction<br>