An observational study in Neoplasm Metastasis / Bone and Bones, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Assiut University · Observational
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.
Adult patients with solid-tumor malignancy with ≥1 lytic bone metastasis (≥1 cm)
Exclusion Criteria:
Participants will undergo 1.5 Tesla MRI examinations including conventional T1/T2-weighted sequences and a T1-weighted Dixon sequence, performed at two time points: at baseline, within one week prior to initiation of chemotherapy or radiotherapy, and again after completion of the treatment course. Fat-only and water-only Dixon image sets will be generated, and regions of interest will be placed on the target lytic bone metastasis and on a reference region of normal-appearing marrow. Relative fat fraction (rFF) will be calculated within each region from the ratio of fat-signal intensity to combined fat-and-water signal intensity, and a normalized fat fraction ratio (FFR) will be derived as lesion rFF divided by reference-region rFF. Diffusion-weighted imaging and apparent diffusion coefficient values will be obtained where feasible as an exploratory measure. No contrast agent, radiotracer, or ionizing radiation is administered as part of the imaging procedure, and no additional invasive
Change in Fat Fraction Ratio of Lytic Bone Metastases
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.
Time frame: Baseline and a follow-up at 4 to 12 weeks after completion of the chemotherapy or radiotherapy course
Comparison of Change in Fat Fraction Ratio Between Chemotherapy and Radiotherapy Subgroups
Comparison of change in the normalized fat fraction ratio (FFR) between participants receiving chemotherapy versus radiotherapy
Time frame: 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
Agreement between two independent observers' fat fraction ratio (FFR) measurements in a subset of re-measured lesions
Time frame: Baseline and a follow-up at 4 to 12 weeks after completion of the chemotherapy or radiotherapy course
No study locations are listed for this record.
Plan to share: Undecided
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Assiut University