30 Participants Needed

[68Ga]-Pentixafor Imaging for Blood Cancers

MM
SK
AN
MSK Radiologist & Nuclear Medicine ...
Overseen ByHeiko Schoder, MD
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the uptake of the imaging agent \[68Ga\]-pentixafor with PET/CT scans in people with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), and non-Hodgkin lymphoma (NHL), or you have histiocytic neoplasms (Langerhans cell histiocytosis (LCH), Erdheim-Chester disease (ECD) and/or Rosai-Dorfman disease (RDD).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What data supports the effectiveness of the treatment [68Ga]-Pentixafor for blood cancers?

[68Ga]-Pentixafor is effective in imaging certain blood cancers, like lymphomas, by targeting CXCR4 receptors, which are often overexpressed in these cancers. It has shown better diagnostic performance than some existing methods and helps in staging and evaluating treatment responses, especially in lymphomas such as mantle cell lymphoma and marginal zone lymphoma.12345

How does [68Ga]-Pentixafor imaging differ from other blood cancer treatments?

[68Ga]-Pentixafor imaging is unique because it uses a radiopharmaceutical that targets specific receptors, allowing for precise imaging of cancer cells. This method is part of a newer approach in nuclear medicine that uses PET scans to provide detailed images, which can help in early diagnosis and personalized treatment planning.678910

Research Team

AN

Anton Nosov, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

Adults over 18 with certain blood cancers like multiple myeloma, non-Hodgkin's lymphoma, or histiocytic neoplasms can join this trial. It's for MSKCC patients who haven't had treatment yet, those whose treatment didn't work, or if it came back. Women must not be pregnant and everyone should be able to handle a PET/CT scan without issues.

Inclusion Criteria

My condition is diagnosed as MGUS, SMM, or MM.
Patients from Memorial Sloan Kettering Cancer Center.
I have a blood cancer that has not been treated, or treatments no longer work, or it has come back.
See 4 more

Exclusion Criteria

My kidney function is low (eGFR<30).
Breast-feeding
Refusal or inability to tolerate the scanning procedure (e.g., due to claustrophobia)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants receive an intravenous bolus of [68Ga]-Pentixafor and undergo PET/CT scans to evaluate uptake dynamics and pharmacokinetics

1.5 hours per scan
1-2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

1 year

Treatment Details

Interventions

  • [68Ga]-Pentixafor
Trial Overview[68Ga]-Pentixafor is being tested as an imaging agent in PET/CT scans to see how well it shows up in various blood cancers including multiple myeloma and non-Hodgkin's lymphoma. The study will help understand the distribution of CXCR4 expression in these conditions.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: [68Ga]-PentixaforExperimental Treatment1 Intervention
An intravenous bolus of 3 -5 mCi \[68Ga\]-Pentixafor will be injected in all participants that will be imaged on a hybrid PET/CT device. Any of the following factors may determine if imaging cannot be performed: tolerance/compliance in the PET/CT scanner; dose availability; dose quality control; availability of the PET/CT scanner or availability of study personnel. \[68Ga\]-Pentixafor uptake dynamics / pharmacokinetics will be evaluated by PET/CT performed with a low-dose CT component used for PET attenuation correction (1-2 mSv). \[68Ga\]-Pentixafor-PET/CT scan duration will be approximately 1.5 hours. Some patients will have two scans.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Pentixapharm AG

Industry Sponsor

Trials
5
Recruited
210+

PentixaPharm GmbH

Industry Sponsor

Trials
2
Recruited
30+

Findings from Research

The developed synthesis process for [68Ga]Ga-PentixaFor using the Gaia/Luna Elysia-Raytest module achieved a high radiochemical yield of 87.0% and excellent radiochemical purity of 99.1%, meeting the standards for injectable radiopharmaceuticals as per European Pharmacopeia.
The stability of the radiotracer was confirmed for up to 4 hours at room temperature, indicating its potential for multi-dose applications in clinical settings, which is crucial for effective imaging of tumors overexpressing the CXCR4 receptor.
Automated synthesis and quality control of [68Ga]Ga-PentixaFor using the Gaia/Luna Elysia-Raytest module for CXCR4 PET imaging.Daniel, T., Balouzet Ravinet, C., Clerc, J., et al.[2023]
68Ga-Pentixafor is a promising radiotracer that helps non-invasively image CXCR4 expression in tumors, which is linked to tumor aggressiveness and metastasis, potentially guiding treatment decisions for patients with solid tumors.
Therapies targeting CXCR4, in combination with 68Ga-Pentixafor imaging, have shown the potential to enhance chemosensitivity and inhibit tumor spread, indicating a new avenue for treating advanced hematological malignancies.
Current Status of 68Ga-Pentixafor in Solid Tumours.Hadebe, B., Sathekge, MM., Aldous, C., et al.[2022]
68Ga-Pentixafor is an innovative radiotracer that effectively targets CXCR4 receptors, which are highly expressed in certain blood cancers, making it useful for imaging hematologic malignancies.
In a case study of a 64-year-old man, 68Ga-Pentixafor PET/CT successfully identified CXCR4-expressing lymph nodes that were missed by the standard 18F-FDG PET/CT, highlighting its potential for better detection of specific malignancies.
CXCR4 Expression Demonstrated by 68Ga-Pentixafor PET/CT Imaging in a Case of Systemic Mastocytosis Mimicking Lymphoma.Kiran, MY., Apaydin Arikan, E., Sanli, Y., et al.[2023]

References

Automated synthesis and quality control of [68Ga]Ga-PentixaFor using the Gaia/Luna Elysia-Raytest module for CXCR4 PET imaging. [2023]
Current Status of 68Ga-Pentixafor in Solid Tumours. [2022]
CXCR4 Expression Demonstrated by 68Ga-Pentixafor PET/CT Imaging in a Case of Systemic Mastocytosis Mimicking Lymphoma. [2023]
Advances in PET Imaging of the CXCR4 Receptor: [68Ga]Ga-PentixaFor. [2023]
The Role of [68Ga]Ga-Pentixafor PET/CT or PET/MRI in Lymphoma: A Systematic Review. [2022]
[68Ga]pentixafor for CXCR4 imaging in a PC-3 prostate cancer xenograft model - comparison with [18F]FDG PET/CT, MRI and ex vivo receptor expression. [2022]
68Ga-Based radiopharmaceuticals: production and application relationship. [2022]
68Ga-P15-041, A Novel Bone Imaging Agent for Diagnosis of Bone Metastases. [2022]
Recent Breakthrough in 68Ga-Radiopharmaceuticals Cold Kits for Convenient PET Radiopharmacy. [2021]
Relationships between uptake of [68Ga]Ga-DOTA-TATE and absorbed dose in [177Lu]Lu-DOTA-TATE therapy. [2022]