Establishment and validation of a clinical threshold criteria for choosing PET imaging tracers for indolent non-Hodgkin's lymphoma.
Xuebing Yu, Hailong Tang, Hengyi Ou...
https://pubmed.ncbi.nlm.nih.gov/41455028Actively Recruiting
Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID06834412
[68Ga]Pentixafor PET/CT for Staging of Hematological Malignancies Compared to [18F]FDG PET/CT
Led by Xijing Hospital · Updated on 2025-03-03
120
Participants Needed
1
Research Sites
26 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the use of 68Ga-pentixafor PET imaging alongside 18F-FDG PET imaging for patients with hematological malignancies such as non-Hodgkin's lymphoma and myeloma. This prospective, open-label study involves 120 patients confirmed by pathology to have these cancers. The goal is to see if 68Ga-pentixafor PET can be a reliable complement to the standard 18F-FDG PET for clinical staging, assessing treatment response, and re-staging. Participants will undergo both 18F-FDG PET/CT and 68Ga-pentixafor PET/CT scans within 7 days after enrollment. Before scans, medical history and lab tests are collected. Pathological results from biopsy or surgery within one month after imaging serve as the diagnostic reference. A follow-up period of six months monitors patients. The imaging agents are prepared under strict quality standards and administered intravenously at specified doses. During the study, researchers collect imaging data, medical history, and lab results, then compare PET/CT findings to pathology outcomes. They measure uptake values like SUVmax and SUVmean of the tracers one day after injection. The study also involves safety monitoring through follow-up visits over six months. Participation duration includes screening, imaging, biopsy, and follow-up until December 2025.
CONDITIONS
Brief Title
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
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Ages 18 to 75 years old
- Confirmed diagnosis by pathology with non-Hodgkin's lymphoma or myeloma
- Willing and able to follow the study protocol
You will not qualify if you...
- Children, pregnant or lactating women
- Severely impaired liver and kidney function (alanine aminotransferase > 8-10 times upper limit of normal, serum creatinine 186-442 umol/L)
- History of allergy to contrast media or other drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - Within 7 days after recruitment
Participants undergo 68Ga-Pentixafor and 18F-FDG PET/CT scans to evaluate hematological tumors.
2 imaging visits (in-person) within 7 days
Surveillance
Duration - 6 months
Participants are followed for 6 months after imaging and pathological confirmation to monitor outcomes.
Periodic follow-up visits over 6 months
Trial Site Locations
Total: 1 location
1
Department ofNuclear Medicine,Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China, 710000
Actively Recruiting
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Research Team
Y
Ying Guo
X
Xuebing Yu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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