CXCR4-targeted PET/CT Imaging in Hematological Malignancies

Hematological Malignancy Clinical Trial

Official title:

An Exploratory, Open-Label, Single Center Study of CXCR4-targeted PET/CT Imaging for Evaluation of Hematological Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05255926
• Other study ID #: ZNYYHYXK0002
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: November 2022
• Source: Zhongnan Hospital
• Contact: Yong He, MD, PhD
• Phone: +86-27-67812698
• Email: vincentheyong[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The incidence and mortality of hematological malignancies remain high. Although 18F-FDG PET/CT imaging is the most common molecular imaging technique used in clinic, the non-specific uptake of 18F-FDG leads to the problems of false negative or positive in hematological malignancies, which makes it difficult to diagnose and evaluate the efficacy. CXCR4 (C-X-C Chemokine Receptor Type 4) is overexpressed in various hematological malignancies, and is associated with poor prognosis. CXCR4-targeted molecular imaging, such as 68Ga-pentixafor PET/CT imaging, has an important potential in hematological malignancies. Therefore, this study will evaluate the efficacy of CXCR4-targeted PET/CT imaging for diagnosis and staging of hematological malignancies, compared with 18F-FDG PET/CT imaging.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Volunteer to participate and sign an informed consent form;

2. 18 = Age = 90 years;

3. Patients with highly suspected, or newly diagnosed, or relapsed hematological malignancies;

4. Willing and able to follow schedule visits, treatment plans and laboratory tests.

Exclusion Criteria:

1. pregnancy or breastfeeding;

2. Allergic to CXCR4-targeted tracers or excipients;

3. Fasting blood glucose level exceeded 11.0 mmol/L prior to injection of 18F-FDG;

4. Those who cannot complete PET/CT scan, including inability to keep supine, claustrophobia, radiation phobia, etc.;

5. Researchers think it is inappropriate to participate in this clinical trial for patients with poor compliance or other unsuitable factors.

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematological Malignancy
• Neoplasms
• PET/CT

Intervention

Drug:
• 68Ga-pentixafor
All participants undergo intravenous administration of 68Ga-pentixafor (1.85-3.71 MBq/kg body weight).

Device:
• PET/CT
PET/CT imaging is performed 1 h after intravenous injection of 68Ga-pentixafor.

Locations

Country	Name	City	State
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Zhongnan Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Duell J, Krummenast F, Schirbel A, Klassen P, Samnick S, Rauert-Wunderlich H, Rasche L, Buck AK, Wester HJ, Rosenwald A, Einsele H, Topp MS, Lapa C, Kircher M. Improved Primary Staging of Marginal-Zone Lymphoma by Addition of CXCR4-Directed PET/CT. J Nucl Med. 2021 Oct;62(10):1415-1421. doi: 10.2967/jnumed.120.257279. Epub 2021 Feb 12. — View Citation

Herrmann K, Lapa C, Wester HJ, Schottelius M, Schiepers C, Eberlein U, Bluemel C, Keller U, Knop S, Kropf S, Schirbel A, Buck AK, Lassmann M. Biodistribution and radiation dosimetry for the chemokine receptor CXCR4-targeting probe 68Ga-pentixafor. J Nucl Med. 2015 Mar;56(3):410-6. doi: 10.2967/jnumed.114.151647. Epub 2015 Feb 19. — View Citation

Pan Q, Cao X, Luo Y, Li J, Feng J, Li F. Chemokine receptor-4 targeted PET/CT with 68Ga-Pentixafor in assessment of newly diagnosed multiple myeloma: comparison to 18F-FDG PET/CT. Eur J Nucl Med Mol Imaging. 2020 Mar;47(3):537-546. doi: 10.1007/s00259-019-04605-z. Epub 2019 Nov 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of 68Ga-pentixafor PET/CT for diagnosis and staging in hematological malignancies.	For subjects with clinically highly suspected, or newly diagnosed, or relapsed hematological malignancies who undergo 68Ga-pentixafor and 18F-FDG PET/CT imaging in one week. Diagnosis and staging results of 68Ga-pentixafor PET/CT will be compared to 18F-FDG PET/CT imaging, pathology and clinical follow-up results.	Two years
Primary	Specificity of 68Ga-pentixafor PET/CT for diagnosis and staging in hematological malignancies.	For subjects with clinically highly suspected, or newly diagnosed, or relapsed hematological malignancies who undergo 68Ga-pentixafor and 18F-FDG PET/CT imaging in one week. Diagnosis and staging results of 68Ga-pentixafor PET/CT will be compared to 18F-FDG PET/CT imaging, pathology and clinical follow-up results.	Two years
Primary	Accuracy of 68Ga-pentixafor PET/CT for diagnosis and staging in hematological malignancies.	Taking the pathology or clinical follow-up as gold standard, the probability of accurate diagnosis and staging (including true positive and true negative) for 68Ga-pentixafor PET/CT imaging will be calculated in subjects with clinically highly suspected, or newly diagnosed, or relapsed hematological malignancies. The result will be compared to 18F-FDG PET/CT imaging.	Two years