Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone: A Whole Body MRI Study

NCT03266744 | Unknown

• 1 other identifier: RD2015-64
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This trial is a feasibility study prior to a planned phase III trial. Currently, assessing response to treatment of metastatic breast cancer in the bone is limited by the technical problems associated with CT scans and bone scans. WB-MRI provides theoretical and practical advantages that allow for more detailed analysis of disease response or progression. This may allow for earlier identification of progressive disease and earlier change in treatment. Participants in the study will have a CT scan, bone scan and WB-MRI at baseline and then repeated CT and WB-MRI scans every 12 weeks (until week 96, and then every 24 weeks) until there is evidence of progressive disease on either of the imaging modalities. In addition to the regular scans on the study, patients will be given the opportunity to participate in a study of how reproducible the findings of WB-MRI scans are. At the point of disease progression, a repeat bone scan is performed and the involvement of the patient in the trial comes to an end.

Conditions

Metastatic Breast Cancer

Keywords

Metastatic Breast Cancer; Whole Body MRI; Computerised Tomography; Bone scan

Outcome Measures

Primary Outcomes (1)

• Disease progression on CT and/or WB-MRI

  Description of the metric used to characterize the specific primary outcome measure, if not included in the primary outcome measure title.

  Up to 96 weeks (from date of consent until the date of first documented progression)

Secondary Outcomes (1)

• Disease progression on CT and/or WB-MRI

  Up to 96 weeks (from date of consent until the date of first documented progression)

Study Arms (2)

Main study group

OTHER

Patients will have repeat CT (Computerised Tomography) scans and WB-MRI (Whole Body Magnetic Resonance Imaging) every 12 weeks until disease progression. A baseline bone scan (99mTc-MDP) will be performed. At the point of disease progression, a repeat bone scan will be obtained in addition to the CT and WB-MRI.

Diagnostic Test: Computerised Tomography; Diagnostic Test: Whole Body Magnetic Resonance Imaging; Diagnostic Test: Bone scan

WB-MRI sub-study group

OTHER

Patients will be given the opportunity to participate in a sub-study of WB-MRI reproducibility. This involves a repeat scan of the Whole Body Magnetic Resonance Imaging (WB-MRI) diffusion-weighted sequences. This will be shorter in duration than the full WB-MRI scan and will take place within one hour of completing the full WB-MRI scan.

Diagnostic Test: Whole Body Magnetic Resonance Imaging

Interventions

Computerised Tomography DIAGNOSTIC_TEST

Main study group

Whole Body Magnetic Resonance Imaging DIAGNOSTIC_TEST

Main study group; WB-MRI sub-study group

Bone scan DIAGNOSTIC_TEST

Main study group

Eligibility Criteria

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

You may qualify if:

• Histological diagnosis of breast cancer
• Single or multiple bone metastases (no extraosseous or non-bony metastatic disease permitted)
• Due to start a new line of either hormone therapy or chemotherapy (use of bisphosphonates / denosumab or targeted agents e.g. trastuzumab in addition to hormone therapy / chemotherapy permitted)
• Aged 18 and over
• Life expectancy of over 6 months
• No current active malignancy other than breast cancer
• Written informed consent must be given according to GCP, and national/local regulations

You may not qualify if:

• Radical treatment to sole site of metastatic disease e.g. Cyberknife to solitary bone metastasis
• Absolute contraindication to MRI studies, CT scans or bone scans
• Pregnancy
• Psychological, familial, sociological or geographical conditions that would hamper compliance with the study protocol; such conditions should be discussed with the patient before registration in the trial before patient registration.

Sponsors & Collaborators

• East and North Hertfordshire NHS Trust: lead

Related Publications (1)

• Kosmin M, Padhani AR, Gogbashian A, Woolf D, Ah-See ML, Ostler P, Sutherland S, Miles D, Noble J, Koh DM, Marshall A, Dunn J, Makris A. Comparison of Whole-Body MRI, CT, and Bone Scintigraphy for Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to Bone. Radiology. 2020 Dec;297(3):622-629. doi: 10.1148/radiol.2020192683. Epub 2020 Oct 20.

  PMID: 33078998 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Dr Andreas Makris

  East and North Hertfordshire NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The reporting radiologist of the WB-MRI will be blinded to the results of the CT. The reporting radiologist of the CT will also be blinded to the results of the WB-MRI. Neither treating clinicians nor patients will be blinded at any point.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: August 30, 2017
• Study Start: April 21, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: August 30, 2017

Record last verified: 2017-08