CTFEA Myeloma Study

NCT04364724 | Unknown DMC

• 1 other identifier: 0273-18-TLV
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients with Multiple Myeloma are monitored for disease progression and for response to treatment by the treating hematologist or oncologist. Laboratory tests are usually utilized for these purposes. The role of imaging is confined to follow-up the progression of visible bone lesions. We suggest that microscopic bone lesions impair bone structure well before they grow enough to be visible on a CT scan. This impairment of bone strength can probably be captured by application of CT-based finite element analysis to the CT scans that were performed for monitoring of progression of the disease.

Conditions

Myeloma Multiple; Metastatic Bone Tumor

Keywords

CT-based finite element analysis; Pathologic fracture; Multiple myeloma; Disease progression; Monitoring; Response to treatment

Outcome Measures

Primary Outcomes (2)

• Change in bone strength

  Identification of changes in bone strength on CT-based FE analysis on three consecutive CT scans that are not apparent to the human eye

  12 months

• Quantification of bone strength

  Quantification of changes in bone strength in normal looking bone and areas of lytic lesions

  12 months

Secondary Outcomes (3)

• Pathological fracture

  12 months of follow up

• Mortality

  12 months

• Loss of ambulatory ability

  12 months

Study Arms (1)

Study group

All patients referred to the Hematology clinic for diagnosis and treatment of active multiple myeloma will be asked to participate in the study and undergo 3 consecutive low-dose CT scans over a period of 12 months. For non-consenting patients only minimal demographic data will be documented. Eligible consenting patients will sign informed consent.

Other: CT-based finite element analysis

Interventions

CT-based finite element analysis OTHER

CTFEA is a computerized analysis of CT-scans which simulates stress testing of finite element models of various bones (in this study - femurs and vertebrae). No intervention is planned - the study is observational. CT scans are performed for follow-up as an accepted standard of care. Secondary use of CT scans for CTFEA is in addition to the standard of care. In a case when CTFEA analysis detects a high risk of pathologic fracture, the treating hematologist will be informed and will refer the patient for evaluation at the National Unit of Orthopedic Oncology.

Also known as: CTFEA

Study group

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Active Multiple Myeloma

You may qualify if:

• All patients with Active Multiple Myeloma

You may not qualify if:

• Inability to provide informed consent or lack of consent.
• Inadequate CT scans

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• Tel Aviv University: collaborator

Related Publications (4)

• Myeloma: diagnosis and management. London: National Institute for Health and Care Excellence (NICE); 2018 Oct. Available from http://www.ncbi.nlm.nih.gov/books/NBK553585/

  PMID: 32045178 BACKGROUND

• Sternheim A, Giladi O, Gortzak Y, Drexler M, Salai M, Trabelsi N, Milgrom C, Yosibash Z. Pathological fracture risk assessment in patients with femoral metastases using CT-based finite element methods. A retrospective clinical study. Bone. 2018 May;110:215-220. doi: 10.1016/j.bone.2018.02.011. Epub 2018 Feb 20.

  PMID: 29475110 BACKGROUND

• Terpos E, Ntanasis-Stathopoulos I, Gavriatopoulou M, Dimopoulos MA. Pathogenesis of bone disease in multiple myeloma: from bench to bedside. Blood Cancer J. 2018 Jan 12;8(1):7. doi: 10.1038/s41408-017-0037-4.

  PMID: 29330358 BACKGROUND

• Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.

  PMID: 7165009 BACKGROUND

Related Links

• International Myeloma Working Group (IMWG): Uniform Response Criteria for Multiple Myeloma. April 21, 2010.

MeSH Terms

Conditions

Multiple Myeloma; Bone Neoplasms; Fractures, Spontaneous; Disease Progression

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases; Fractures, Bone; Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Amir Sternheim, MD

CONTACT

0524262589; amirst@tlvmc.gov.il

Haggai Schermann, MD

CONTACT

0528771014; sheralmi@bu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: April 28, 2020
• Study Start: June 1, 2020
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2024
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share