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Neoplasm Metastasis / Bone and BonesNCT07848516

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

An observational study of Neoplasm Metastasis / Bone and Bones, run by Assiut University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasm Metastasis / Bone and Bones
What is being tested?
MRI Non-contrast
How many people
84 participants
Where
1 siteEgypt
Study dates
10 Nov 2026to 1 Nov 2029
How long will I take part?
3 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ibrahem Abdelnaser Zohry, MBBCh contact

+201555433075

ibrahim.18313355@med.aun.edu.eg

Egypt1 site, 1 recruiting

  • South Egypt Cancer Institute, Assiut University

    Asyut, Assiut Governate, 71515

    Ibrahem Zohry, M.B.B.Ch, +201555433075, ibrahim.18313355@med.aun.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: 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.

Being tested
MRI Non-contrast
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRI Non-contrastDiagnostic test

    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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and a follow-up at 4 to 12 weeks after completion of the chemotherapy or radiotherapy course

Secondary outcomes (2)

  1. 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

    Measured: Baseline and a follow-up at 4 to 12 weeks after completion of the chemotherapy or radiotherapy course

  2. 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

    Measured: Baseline and a follow-up at 4 to 12 weeks after completion of the chemotherapy or radiotherapy course

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2026
  2. Study start10 Nov 2026 (estimated)
  3. Primary completion1 Mar 2029 (estimated)
  4. Study completion1 Nov 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
84 participants (estimated)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07848516
Sponsor's protocol ID
Bone metastases fat fraction
Status last verified
Sep 2026
First submitted
16 Sep 2026
Last updated
4 Nov 2026
Results posted
No
Individual data sharing
Undecided

Publications

  • Park S, Do Huh J. Differentiation of bone metastases from benign red marrow depositions of the spine: the role of fat-suppressed T2-weighted imaging compared to fat fraction map. Eur Radiol. 2022 Oct;32(10):6730-6738. doi: 10.1007/s00330-022-08965-3. Epub 2022 Jul 7.

    PubMed 35798881

  • Takasu M, Kondo S, Akiyama Y, Takahashi Y, Maeda S, Baba Y, Kawase T, Ichinohe T, Awai K. Assessment of early treatment response on MRI in multiple myeloma: Comparative study of whole-body diffusion-weighted and lumbar spinal MRI. PLoS One. 2020 Feb 27;15(2):e0229607. doi: 10.1371/journal.pone.0229607. eCollection 2020.

    PubMed 32106239

  • Koutoulidis V, Terpos E, Papanikolaou N, Fontara S, Seimenis I, Gavriatopoulou M, Ntanasis-Stathopoulos I, Bourgioti C, Santinha J, Moreira JM, Kastritis E, Dimopoulos MA, Moulopoulos LA. Comparison of MRI Features of Fat Fraction and ADC for Early Treatment Response Assessment in Participants with Multiple Myeloma. Radiology. 2022 Jul;304(1):137-144. doi: 10.1148/radiol.211388. Epub 2022 Apr 5.

    PubMed 35380497

  • Schmeel FC, Vomweg T, Traber F, Gerhards A, Enkirch SJ, Faron A, Sprinkart AM, Schmeel LC, Luetkens JA, Thomas D, Kukuk GM. Proton density fat fraction MRI of vertebral bone marrow: Accuracy, repeatability, and reproducibility among readers, field strengths, and imaging platforms. J Magn Reson Imaging. 2019 Dec;50(6):1762-1772. doi: 10.1002/jmri.26748. Epub 2019 Apr 13.

    PubMed 30980694

  • Castagnoli F, Donners R, Tunariu N, Messiou C, Koh DM. Relative fat fraction of malignant bone lesions from breast cancer, prostate cancer and myeloma are significantly lower than normal bone marrow and shows excellent interobserver agreement. Br J Radiol. 2023 Dec;96(1152):20230240. doi: 10.1259/bjr.20230240. Epub 2023 Oct 31.

    PubMed 37750943

  • Azma YN, Boci N, Abramowicz K, Russo L, Orton MR, Tunariu N, Koh DM, Charles-Edwards G, Collins DJ, Winfield JM. Influence of imaging method on fat fraction estimation for assessing bone marrow in metastatic prostate cancer. Eur Radiol. 2025 Oct;35(10):6039-6051. doi: 10.1007/s00330-025-11564-7. Epub 2025 Apr 11.

    PubMed 40214737

  • Lecouvet FE, Taihi L, Kirchgesner T, Pasoglou V, Halut M, Tuba Sanal H, Gitto S, Martin-Noguerol T, Vasilevska-Nikodinovska V, Vanhoenacker F, Vilanova JC. ESR Essentials: bone marrow MRI in oncology-practice recommendations by the European Society of Musculoskeletal Radiology. Eur Radiol. 2026 Jul;36(7):5414-5428. doi: 10.1007/s00330-025-12307-4. Epub 2026 Feb 9.

    PubMed 41663831

  • Carmona R, Pritz J, Bydder M, Gulaya S, Zhu H, Williamson CW, Welch CS, Vaida F, Bydder G, Mell LK. Fat composition changes in bone marrow during chemotherapy and radiation therapy. Int J Radiat Oncol Biol Phys. 2014 Sep 1;90(1):155-63. doi: 10.1016/j.ijrobp.2014.05.041. Epub 2014 Jul 8.

    PubMed 25015207

  • Latifoltojar A, Hall-Craggs M, Bainbridge A, Rabin N, Popat R, Rismani A, D'Sa S, Dikaios N, Sokolska M, Antonelli M, Ourselin S, Yong K, Taylor SA, Halligan S, Punwani S. Whole-body MRI quantitative biomarkers are associated significantly with treatment response in patients with newly diagnosed symptomatic multiple myeloma following bortezomib induction. Eur Radiol. 2017 Dec;27(12):5325-5336. doi: 10.1007/s00330-017-4907-8. Epub 2017 Jun 27.

    PubMed 28656463

  • Park S, Huh JD. Bone metastases with post-treatment intralesional fatty content of the spine: imaging features from T1-weighted imaging with CT finding correlations. Acta Radiol. 2023 Jan;64(1):153-163. doi: 10.1177/02841851211058930. Epub 2021 Dec 1.

    PubMed 34851180

  • Qin C, Goldberg O, Kakar G, Wan S, Haroon A, Azam A, Adeleke S. MRI fat fraction imaging of nodal and bone metastases in prostate cancer. Eur Radiol. 2023 Aug;33(8):5851-5855. doi: 10.1007/s00330-023-09527-x. Epub 2023 Mar 16.

    PubMed 36928564

Questions about this trial

What is this clinical trial studying?

An observational study of Neoplasm Metastasis / Bone and Bones, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ibrahem Abdelnaser Zohry, MBBCh (+201555433075, ibrahim.18313355@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07848516, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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