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Trial Title:
Ga-68-CXCR4 PET/CT in Indolent B-cell Lymphoma
NCT ID:
NCT06461182
Condition:
Indolent B-Cell Non-Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Conditions: Keywords:
Ga-68-CXCR4 PET/CT
indolent B-cell lymphoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Ga-68-CXCR4
Description:
Ga-68-CXCR4 for PET/CT procedure in Indolent B-cell Lymphoma
Arm group label:
Ga-68-CXCR4 PET/CT in Indolent B-cell Lymphoma
Other name:
PET/CT
Summary:
This study explores the efficacy of Ga-68-PentixaFor PET/CT in detecting, assessing
treatment response, and monitoring the risk of aggressiveness in indolent B-cell
lymphoma. The background introduces CXCR4 and discusses its role in cancer research.
Currently, FDG-PET is the primary imaging tool for lymphoma staging, but it lacks
diagnostic accuracy for low-grade lymphomas. Ga-68-PentixaFor PET demonstrates promising
detection capabilities across various lymphomas, suggesting its potential as a superior
imaging modality for low-grade lymphomas.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- The pathological diagnosis is slow-growing lymphoma, such as: marginal-zone B-cell
lymphoma, Waldenstrom macroglobulinemia lymphocytic lymphoma, CLL/SLL, mantle cell
lymphoma.
- Have undergone or planned to undergo FDG PET scan for indications including initial
staging, therapeutic response evaluation, or follow-up examinations within 3 to 6
months in the clinical observation group.
- Able to lie flat for at least 30 minutes.
- Signing the subject consent form.
- ECOG grade 0-2.
- The timing of F-18-FDG usage in this trial follows the "Lymphoma Treatment
Principles" of our institution.
Exclusion Criteria:
- Pregnant woman
- Severe renal impairment (eGRF< 30ml/min)
- Known or suspected allergy to radiopharmaceuticals
- Concurrent or previous diagnosis of malignancies other than lymphoma
- Inability to undergo the necessary PET scan procedure
- Refusal or unwillingness to sign the informed consent form
- Severe medical conditions (severe disabilities, mental disorders)
Gender:
All
Minimum age:
20 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Koo Foundation Sun Yat-Sen Cancer Center
Address:
City:
Taipei
Zip:
1125019
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Yu Yi Huang, MD
Phone:
+886 28970011
Phone ext:
1121
Email:
yuyi@kfsyscc.org
Contact backup:
Last name:
Cheng Ling Yang, B.Rad.
Phone:
+886 28970011
Phone ext:
1167
Email:
androgyny@kfsyscc.org
Start date:
April 29, 2024
Completion date:
April 2027
Lead sponsor:
Agency:
Koo Foundation Sun Yat-Sen Cancer Center
Agency class:
Other
Source:
Koo Foundation Sun Yat-Sen Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06461182
