A Study Evaluating the Value of 68Ga-Pentixafor PET Imaging in the Staging of Hematological Tumor, and Comparing It with 18F-FDG PET/CT Imaging

NCT06834412 | Recruiting

• 1 other identifier: KY20212119-F-1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, open-label, single-center clinical study targeting hematological malignancies. 120 patients with a confirmed by pathology of non-Hodgkin's lymphoma or myeloma were included. Qualified subjects will undergo 18F-FDG PET/CT and 68Ga-Pentixafor PET/CT examination. The aim is to To investigate whether 68Ga-pentixafor PET imaging can be used as a reliable complement to 18F-FDG PET imaging for clinical staging, treatment response evaluation, and re-staging of patients with hematological malignancies.

Conditions

Hematological Malignancies

Keywords

68Ga-Pentixafor; hematological malignancies; 18F-FDG; staging

Outcome Measures

Primary Outcomes (3)

• Maximum Standardized uptake value (SUVmax)

  Maximum Standardized uptake value (SUVmax) of \[68Ga\]Pentixafor and \[18F\]FDG in the included subjects' primary and/or metastatic lesions.

  1 day from injection of the tracer

• Mean Standardized Uptake Value(SUVmean) of liver

  Mean Standardized uptake value (SUVmean) of \[68Ga\]RCCB6 and \[68Ga\]PSMA in the included subjects' liver.

  1 day from injection of the tracer

• Mean Standardized uptake value (SUVmean)

  Mean Standardized uptake value (SUVmean) of \[68Ga\]Pentixafor and \[18F\]FDG in the included subjects' primary and/or metastatic lesions.

  1 day from injection of the tracer

Study Arms (1)

before-after study in the same patient

EXPERIMENTAL

This is a prospective, open-label, single-center clinical study for hematological malignancies. 120 patients confirmed by pathology of having NHLs or myeloma were included. Qualified subjects underwent 18F-FDG and 68Ga-Pentixafor PET/CT scans within 7 days after recruited. Patient medical history was collected and laboratory tests were performed before the examination, and a biopsy or surgery was performed to obtain pathological results within 1 month after the examination, followed by a 6-month follow-up. The pathological results were used as the diagnostic gold standard.

Diagnostic Test: 68Ga-Pentixafor and 18F-FDG PET/CT Scan

Interventions

68Ga-Pentixafor and 18F-FDG PET/CT Scan DIAGNOSTIC_TEST

The imaging agent 68Ga-Pentixafor and 18F-FDG used in this project is synthesized following the standards for radiopharmaceutical production, with reference to the Chinese Pharmacopoeia (quality standards for 18F-FDG). The pH value is about 4; the radiochemical purity is not less than 95%, and the bacterial endotoxin content in each milliliter of solution is less than 15EU; the radioactive concentration is not less than 37 MBq/mL; the solvent residues comply with the regulations. Specification: 185\~1850 MBq/ml Characteristics: Clear, colorless, no visible particles. Radioactive physical half-life: 68Ga is 68 minutes. Expiry: Calculated from the time of labeling, stable for 3 half-lives. Administration method: Intravenous injection. Dosage: 0.05-0.1mCi/kg, flush with 5 mL of saline after injection.

before-after study in the same patient

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18 to 75 years old Confirmed by pathology with NHLs or myeloma Willing and able to follow the study protocol.

You may not qualify if:

• Children, pregnant or lactating women Severely impaired liver and kidney function (alanine aminotransferase \> 8-10 times the upper limit of normal, serum creatinine 186-442 umol/L) With a history of allergy to contrast media or other drugs

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Department ofNuclear Medicine,Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710000, China

RECRUITING

Related Publications (1)

• Yu X, Tang H, Ou H, Quan Z, Li G, Gao G, Wang J, Kang F. Establishment and validation of a clinical threshold criteria for choosing PET imaging tracers for indolent non-Hodgkin's lymphoma. EJNMMI Res. 2025 Dec 27. doi: 10.1186/s13550-025-01368-7. Online ahead of print.

  PMID: 41455028 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Ying Guo

CONTACT

0086+15991459177; guoying01192022@163.com

Xuebing Yu

CONTACT

0086+18967285780; 786979204@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: before-after study in the same patient

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 19, 2025
• Study Start: November 3, 2021
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 3, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)