Whole Body Magnetic Resonance Imaging Study

NCT ID: NCT04117594

Last Updated: 2021-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-09
• Study Completion Date: 2021-06-30

Brief Summary

In prostate cancer bone is the most common site for cancer spread, causing pain, fractures, nerve compression and death.

New therapies are available for treating bone disease from cancer and this means that by maintaining patients on drugs that are effective and switching patients to other drugs when current treatment becomes ineffective, patients can be maintained 'better for longer'. However, to do this, it is necessary to accurately tell whether a given treatment is working or not.

In this study, the investigators will perform whole body MRI scans, which include a special scan called diffusion-weighted MRI (DWI MRI) that can provide more information about the participants extent of disease. The investigators aim to show that this test is better than the standard tests of CT and bone scan currently used in the NHS to monitor bone disease. The information from this study will be used to test a special software so that the test may more widely benefit patients across the NHS in the future.

Detailed Description

In patients with prostate cancer the current methods to assess treatment response of bone disease such as computer tomography (CT) and bone scan (BS)are unreliable, insensitive to bone disease and have limited criteria to assess disease response confined to bones. Blood tests are inaccurate although some newer tests (e.g. circulating tumour cells tests) show promise but are still under investigation and nuclear medicine investigations such as PET/CT imaging have higher sensitivity, meaning they can detect more sites of disease who are indeed disease than CT or BS but they are more costly and less widely available compared with MRI within the NHS.

For this study the Whole body MRI (WB-MRI) includes a measurement called diffusion-weighted imaging (DWI) which is relatively new and has a high sensitivity for bone metastases. This technique can be used to measure total bone disease volume (TDV) and the disease apparent diffusion coefficient (ADC) which reflects the tumour tissue cell density. Previous studies have shown good reproducibility of both these measurements and a significant increase in the mean tumour ADC is observed in patients who are responding to effective treatment.

However WB-MRI application across the NHS is ad-hoc, CT and BS techniques are entrenched within clinical practice despite their known limitations. Another factor that limits wider adoption of WB-MRI is the lack of sophisticated analysis software to enable disease across the body to be quickly evaluated.

This multi-centre imaging study will provide the opportunity to evaluate the performance of WB-MRI with a novel software diagnostics for evaluating the treatment response of advanced prostate cancer patients.

This prototype can used to evaluate WB-MRI data from different scanners and address a current major unmet need for the treatment and follow-up of patients with bone disease from cancers, so that the test may more widely benefit patients across the NHS in the future.

Conditions

Advanced Prostate Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

WB-MRI

Whole body MRI with diffusion-weighted imaging (DWI)

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Written informed consent

2. Age ≥18 years

3. Patients with APC with predominantly bone disease confirmed by bone scan (within 6 weeks) or CT (within 6 weeks), of starting treatment (Cycle 1 Day 1). Patients with local recurrence and bone metastases with an associated soft tissue component, will be allowed into the trial. Pelvic lymphadenopathy <1.5cm in short axis is not an exclusion.

4. Systemic therapy indicated for disease progression, as clinically indicated.

Exclusion Criteria

1. Patient is claustrophobic.

2. Contraindications to MRI examination (e.g. cardiac pacemakers, cochlear implants).

3. Measurable soft tissue or lymph node metastases or any metastatic disease outside the bone that is RECIST measurable will be an exclusion (unless it is pelvic nodal disease <1.5cm in short axis). Bone metastases with associated soft tissue components will also not be an exclusion.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

Institute of Cancer Research, United Kingdom

OTHER

Sponsor Role: collaborator

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, United Kingdom

Countries

United Kingdom

Other Identifiers

CCR 5035

Identifier Type: -

Identifier Source: org_study_id