Change in Fat Fraction Quantification Before and After Treatment in Bone Metastases

September 23, 2026 updated by: Ibrahem Abdelnaser Ahmed Zohry, Assiut University

Fat Fraction Quantification of Bone Metastases Before and After Treatment Using 1.5 Tesla MRI T1-Weighted Dixon Sequence

Bone metastases are a common and serious complication of cancer. Treatment response is currently judged mainly by delayed changes on CT scans or X-rays, a process that can take months and sometimes produces misleading results. The study investigates whether a specialized, radiation-free MRI technique called Dixon imaging can detect early signs of treatment response by measuring fat content within bone metastases before and after chemotherapy or radiotherapy. As tumor tissue within a bone lesion responds to treatment, the lesion is expected to be gradually replaced by fatty marrow, a change that can be quantified using the Dixon MRI method. Adult patients with a solid-tumor cancer and at least one lytic (bone-destroying) metastasis will undergo an MRI scan before starting treatment and a second MRI scan after completing chemotherapy or radiotherapy. Change in fat content within the lesion, and relative to normal marrow, will be measured and compared between patients receiving chemotherapy versus radiotherapy. The study does not involve additional radiation, contrast injection, or invasive procedures beyond standard MRI, and does not influence treatment decisions, which remain under the direction of the treating oncology team.

Study Overview

Status

Not yet recruiting

Conditions

Neoplasm Metastasis / Bone and Bones

Intervention / Treatment

Diagnostic test: MRI Non-contrast

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Ibrahem Abdelnaser Zohry, MBBCh
Phone Number: +201555433075
Email: ibrahim.18313355@med.aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients with solid-tumor malignancy with ≥1 lytic bone metastasis (≥1 cm)

Description

Inclusion Criteria:

Solid-tumor malignancy with ≥1 lytic bone metastasis (≥1 cm) confirmed on CT. (When a patient has more than one qualifying lytic lesion, the largest and/or most accessible lesion (whichever allows more reliable, artifact-free ROI placement) will be selected for analysis.)
Scheduled for chemotherapy or radiotherapy to the involved region.
Age ≥18, able to undergo MRI,
Informed consent given.

Exclusion Criteria:

Sclerotic/mixed lesions.
Prior focal treatment to the lesion.
Pathological fracture at the site.
Patients receiving concurrent bone-targeting therapy (bisphosphonates or denosumab) during the study period, as these independently alter marrow fat content.
MRI contraindications.
Inability to complete follow-up scan.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: COHORT
Time Perspectives: PROSPECTIVE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fat Fraction Ratio of Lytic Bone Metastases Time Frame: Baseline and a follow-up at 4 to 12 weeks after completion of the chemotherapy or radiotherapy course	Change in the normalized fat fraction ratio (FFR, lesion rFF divided by reference-region rFF), calculated as the difference between pre-treatment and post-treatment values for each participant.	Baseline and a follow-up at 4 to 12 weeks after completion of the chemotherapy or radiotherapy course

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Change in Fat Fraction Ratio Between Chemotherapy and Radiotherapy Subgroups Time Frame: Baseline and a follow-up at 4 to 12 weeks after completion of the chemotherapy or radiotherapy course	Comparison of change in the normalized fat fraction ratio (FFR) between participants receiving chemotherapy versus radiotherapy	Baseline and a follow-up at 4 to 12 weeks after completion of the chemotherapy or radiotherapy course
Inter-observer Agreement for Fat Fraction Ratio Measurements Time Frame: Baseline and a follow-up at 4 to 12 weeks after completion of the chemotherapy or radiotherapy course	Agreement between two independent observers' fat fraction ratio (FFR) measurements in a subset of re-measured lesions	Baseline and a follow-up at 4 to 12 weeks after completion of the chemotherapy or radiotherapy course

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

November 1, 2029

Study Registration Dates

First Submitted

September 16, 2026

First Submitted That Met QC Criteria

September 23, 2026

First Posted (Actual)

September 30, 2026

Study Record Updates

Last Update Posted (Actual)