Efficacy of 68Ga-Pentixafor PET/MR in Detecting Non-Hodgkin Lymphoma and Multiple Myeloma Lesions

NCT06720207 | Not Yet Recruiting DMC

• 1 other identifier: SEH-2024210
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study, the investigators intend to utilize 68Ga-Pentixafor Positron Emission Tomography（PET） imaging for patients diagnosed with non-Hodgkin lymphoma (NHL) and multiple myeloma (MM). The investigators will compare the imaging results with those obtained from 18F-FDG imaging, and a correlation analysis will be performed to assess progression-free survival among patients. This analysis aims to evaluate the diagnostic efficacy and the potential for early prediction of treatment efficacy associated with 68Ga-Pentixafor in these specific conditions.

Conditions

Non Hodgkin's Lymphoma; Multiple Myeloma (MM)

Keywords

PET/MR; Non Hodgkin's Lymphoma; multiple myeloma

Outcome Measures

Primary Outcomes (2)

• Ann Arbor staging

  All patients were classified into stages I-IV based on Ann Arbor staging according to visual methods.

  After the patient signs the informed consent form and completes the scan, an average of 2 days.

• Metabolic parameters

  Calculate maximum standardized uptake value (SUVmax (lesion)) of all affected lymphoma and extranodal organs. Set a region of interest with a diameter of approximately 10mm in the descending segment of the thoracic aorta, calculate the standardized uptake value (SUVmean) of the mediastinal blood pool, calculate SUVmax (lesion)/SUVmean (blood pool).

  After the patient signs the informed consent form and completes the scan, an average of 2 days.

Study Arms (1)

Research group

It is expected to include 30 newly diagnosed NHL or MM patients, and the tracer radiation used in the study is extremely small and will not have any physiological effects on the subjects.

Eligibility Criteria

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

Study Population

All patients who meet the inclusion and exclusion criteria and are willing to follow the research process.

You may qualify if:

• Age of 18 years or older
• ECOG \< 2
• Newly diagnosed patients with NHL and MM who have been confirmed or are highly suspected based on pathological examination
• Completion of 18F-FDG PET/CT or PET/MR imaging within the past week in our department

You may not qualify if:

• Pregnant and breastfeeding women;
• Individuals with severe hepatic and renal failure;
• Patients with concurrent malignancies;
• Individuals unable to remain supine for a duration of 30 minutes to complete the examination;
• Patients with diagnosed claustrophobia;
• Patients containing metallic implants;
• Individuals deemed unsuitable for participation in clinical trials by researchers.

Sponsors & Collaborators

• Shanghai East Hospital: lead

MeSH Terms

Conditions

Multiple Myeloma

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

Central Study Contacts

Jie Ding, MD

CONTACT

086-38804518; dingjie940406@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 6, 2024
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: June 27, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share