- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07848516
Change in Fat Fraction Quantification Before and After Treatment in Bone Metastases
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Ibrahem Abdelnaser Zohry, MBBCh
- Telefonnummer: +201555433075
- E-post: ibrahim.18313355@med.aun.edu.eg
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Adult patients with solid-tumor malignancy with ≥1 lytic bone metastasis (≥1 cm)
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Fat Fraction Ratio of Lytic Bone Metastases
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Comparison of Change in Fat Fraction Ratio Between Chemotherapy and Radiotherapy Subgroups
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Bone metastases fat fraction
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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