Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06834412

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hematological Malignancies Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department ofNuclear Medicine,Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710000, China

Location status: Recruiting

Location contact

Ying Guo

CONTACT

[email protected]

0086+15991459177

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Maximum Standardized uptake value (SUVmax)

    Time frame: 1 day from injection of the tracer

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

  2. Mean Standardized Uptake Value(SUVmean) of liver

    Time frame: 1 day from injection of the tracer

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

  3. Mean Standardized uptake value (SUVmean)

    Time frame: 1 day from injection of the tracer

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

Study contacts

Contact information is provided by the study sponsor or research team.

Xuebing Yu

CONTACT

[email protected]

0086+18967285780

Ying Guo

CONTACT

[email protected]

0086+15991459177

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

[68Ga]Pentixafor PET/CT for Staging of Hematological Malignancies: Comparison to [18F]FDG PET/CT

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 19, 2025
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.