Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Value of Chemokine Receptor CXCR4 Imaging for Diagnosis and Prognostic Evaluation in Lymphoproliferative Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04504526
Recruitment Status : Recruiting
First Posted : August 7, 2020
Last Update Posted : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
Weibing Miao, PhD, First Affiliated Hospital of Fujian Medical University

Tracking Information
First Submitted Date  ICMJE August 1, 2020
First Posted Date  ICMJE August 7, 2020
Last Update Posted Date August 7, 2020
Estimated Study Start Date  ICMJE August 2020
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2020)
  • SUVmax [ Time Frame: through study completion, an average of 3 years ]
    SUVmax of focal lesions are measured on 68Ga-Pentixafor PET/CT. The SUVmax of the liver, and/or mediastinal blood pool, and/or L3 vertebra are defined as the background.
  • The time for patient's survival [ Time Frame: through study completion, an average of 3 years ]
    Investigators follow up and record the time for patient's survival. To investigate the ralationship between initial SUVmax of focal lesions and survival. Finally, the prognostic evaluation of 68Ga-Pentixafor PET/CT for lymphoproliferative diseases in comparison with 18F-FDG PET/CT.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2020)
Diagnostic sensitivity and specficity in special type of lymphoma [ Time Frame: through study completion, an average of 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Value of Chemokine Receptor CXCR4 Imaging for Diagnosis and Prognostic Evaluation in Lymphoproliferative Diseases
Official Title  ICMJE Value of Chemokine Receptor CXCR4-targeting Molecular Imaging for Diagnosis and Prognostic Evaluation in Lymphoproliferative Diseases
Brief Summary Chemokine receptor CXCR4 is normally expressed on T-lymphocytes, B-lymphocytes, monocytes, macrophages, neutrophils and eosinophils as well as hematopoietic stem and progenitor cells (HSPC) in the bone marrow. 68Ga-Pentixafor PET/CT represents a promising method for the in vivo assessment of the CXCR4 expression status in cancer patients, especially in hematologic malignancies. This prospective study is going to investigate whether metabolic characterization by 68Ga-Pentixafor PET/CT may be superior for diagnosis, risk stratification, and the prognostic evaluation in lymphoproliferative diseases.
Detailed Description

Lymphoma:

The marginal zone lymphoma, plasma cell lymphoma, T-cell-lymphoma frequently do not present with an elevated FDG uptake. However, lymphoma is a frequent cancer with high CXCR4 expression. The previous studies showed 68Ga-pentixafor-PET seems to be a highly selective and specific method for the in vivo quantification of CXCR4 expression. Thus, our study is going to investigate the value of 68Ga-pentixafor-PET/CT for the diagnosis and prognostic evaluation of CXCR4 expression in lymphoma.

Multiple myeloma:

Multiple myeloma (MM) is characterized by the neoplastic proliferation of plasma cells producing a monoclonal immunoglobulin. Minimal residual disease (MRD) status is an important predictor of clinical outcome in MM. But it is difficult to assess the accurate MRD status because of the significant heterogeneity characterizing with 18F-FDG PET/CT. Studies showed Chemokine receptor CXCR4 was expressed in MM cells and CXCR4-targeting molecular imaging-68Ga-Pentixafor PET/CT could be a promising technique to evaluate the extent of MM with higher accuracy. This prospective study is going to investigate the value of 68Ga-Pentixafor PET/CT for the diagnosis and prognostic evaluation of CXCR4 expression in MM.

Leukemia: Leukemia is the second largest family of hematological malignancies after the lymphomas, and, depending on the subtype, may show a considerable overlap of histological features with the latter. The four main kinds of leukemia are, in the order of their prevalence. Imaging has traditionally played a limited role in the work-up of leukemias, with regard to detection, staging, and response assessment. 18F-FDG PET/CT is not recommended for routine evaluation of CLL, because the disease shows low uptake in the majority of cases. Although, the clinical utility of MRI lies in the detection of bone marrow abnormalities that are suspicious for leukemia in adult and pediatric patients with unclear musculoskeletal symptoms with its reduced radiation dose (in comparison with PET/CT). However, it may become more attractive with the use of newer, non-FDG PET radiotracers. High CXCR4 expression is known to be associated with poor prognosis in CLL. Recently, the feasibility of 68Ga-Pentixafor PET has also been demonstrated for CLL and AML. This prospective study is going to investigate the value of 68Ga-Pentixafor PET/CT for the diagnosis and prognostic evaluation of CXCR4 expression in leukemia.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Lymphoma
  • Multiple Myeloma
  • Leukemia
Intervention  ICMJE Drug: 68Ga-Pentixafor
Intravenous injection of one dose of 74-148 MBq (2-4 mCi) 68Ga-Pentixafor. Tracer doses of 68Ga- Pentixafor will be used to image lesions by PET/CT.
Study Arms  ICMJE Experimental: 68Ga-Pentixafor, PET/CT
PET/CT perform after injecting 68Ga-Pentixafor
Intervention: Drug: 68Ga-Pentixafor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 6, 2020)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • suspected or confirmed untreated Lymphoproliferative diseases patients
  • 18F-FDG PET/CT within two weeks
  • signed written consent.

Exclusion Criteria:

  • pregnancy
  • breastfeeding
  • known allergy against Pentixafor
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Weibing Miao, M.D. +86-599-87981618 miaoweibing@126.com
Contact: Zhenying Chen +86-599-87981619 chenzhenying726@foxmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04504526
Other Study ID Numbers  ICMJE FirstAHFMUCXCR4
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Weibing Miao, PhD, First Affiliated Hospital of Fujian Medical University
Study Sponsor  ICMJE First Affiliated Hospital of Fujian Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Weibing Miao, M.D. First Affiliated Hospital of Fujian Medical University
PRS Account First Affiliated Hospital of Fujian Medical University
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP