[68Ga]-Pentixafor Imaging for Blood Cancers

Overseen By Heiko Schoder, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Breast-feeding, Renal disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of a new imaging agent, [68Ga]-pentixafor, in detecting certain blood cancers using PET/CT scans. Researchers seek to understand how this agent behaves in conditions such as non-Hodgkin lymphoma, some types of multiple myeloma, and histiocytic disorders. It is suitable for individuals with these specific blood cancers who have not responded to other treatments. Participants must be able to undergo the scanning process without issues like claustrophobia. As an Early Phase 1 trial, participants will be among the first to help researchers understand how this new imaging agent functions in people.

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 prior data suggests that this imaging agent is safe for use in humans?

Research shows that [68Ga]-Pentixafor is under study for imaging blood cancers and some other conditions. This process uses a small amount of a radioactive substance to help doctors visualize specific cells in the body.

In studies so far, [68Ga]-Pentixafor has been used in PET/CT scans to detect blood cancers and other tumors. No major safety concerns have been reported. The imaging agent is usually well-tolerated, with most people not experiencing serious side effects. However, as this is an early-stage trial, much remains to be learned about its safety in humans.

Prospective participants should discuss any concerns with the trial team, who can provide more detailed information based on current findings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

[68Ga]-Pentixafor is unique because it targets the CXCR4 receptor, which is often overexpressed in blood cancers. Unlike traditional imaging agents that may not be as specific, this radiotracer binds directly to cancer cells, potentially offering a clearer picture of the disease's spread. Researchers are excited about this treatment because it could lead to more precise diagnostics, helping tailor treatments to individual patients and possibly improving outcomes. Additionally, the use of PET/CT imaging provides detailed insights into the pharmacokinetics of the cancer, which is a significant step forward in understanding and managing these types of cancers.

What evidence suggests that [68Ga]-Pentixafor imaging is effective for blood cancers?

Research has shown that \[68Ga\]-Pentixafor PET/CT scans, which participants in this trial will receive, can be more effective than traditional FDG PET/CT scans for imaging blood cancers like multiple myeloma and non-Hodgkin lymphoma. In studies, \[68Ga\]-Pentixafor detected these cancers more effectively. This imaging agent targets a specific protein (CXCR4) often found in large amounts on cancer cells, potentially improving the detection and assessment of blood cancers. Early findings suggest it could provide more precise information than standard imaging methods. ^{1 2 4 6 7}

Who Is on the Research Team?

Anton Nosov, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: [68Ga]-Pentixafor Experimental Treatment 1 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.

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+

Published Research Related to This Trial

The study found that the uptake of [68Ga]Pentixafor in PC-3 prostate cancer tumors was significantly lower than that of [18F]FDG, indicating that [68Ga]Pentixafor may not be as effective for imaging prostate cancer in this model.

There was no significant correlation between the tumor uptake of [68Ga]Pentixafor and the expression of the CXCR4 receptor, suggesting that the low uptake may be due to the low levels of CXCR4 on the surface of PC-3 cells, which could limit its effectiveness as a tracer for prostate cancer imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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. Schwarzenböck, SM., Stenzel, J., Otto, T., et al.[2022]

68Ga-based imaging agents significantly enhance the capabilities of positron emission tomography (PET) for improved diagnostics and personalized medicine.

The review highlights the importance of regulatory requirements in the production and application of 68Ga radiopharmaceuticals, which are crucial for both pre-clinical and clinical research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-Based radiopharmaceuticals: production and application relationship. Velikyan, I.[2022]

68Ga-PET is a valuable diagnostic tool for detecting and monitoring cancers, thanks to its easy availability and cost-effective production from a long-lived 68Ge/68Ga generator.

The development of simple cold kits for 68Ga-radiopharmaceuticals has made it easier to use in clinical settings, particularly for imaging neuroendocrine tumors and prostate cancer, paving the way for broader applications in nuclear medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent Breakthrough in 68Ga-Radiopharmaceuticals Cold Kits for Convenient PET Radiopharmacy. Satpati, D.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Status of 68Ga-Pentixafor in Solid Tumours. Hadebe, B., Sathekge, MM., Aldous, C., et al.[2022]

[68Ga]Ga-PentixaFor is a promising PET imaging agent that targets the CXCR4 receptor, showing high specificity and selectivity in preclinical cancer studies, particularly for multiple myeloma and certain lymphomas.

With a favorable safety profile and rapid clearance from the body, [68Ga]Ga-PentixaFor has been studied in over 1000 patients, indicating its potential for both diagnostic and therapeutic applications in hematologic malignancies and other diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in PET Imaging of the CXCR4 Receptor: [68Ga]Ga-PentixaFor. Lindenberg, L., Ahlman, M., Lin, F., et al.[2023]

The novel radiotracer 68Ga-P15-041 PET/CT demonstrated superior efficacy in detecting bone metastases compared to the traditional 99mTc-MDP whole-body bone scintigraphy, identifying 162 metastatic sites versus 81, with higher sensitivity (93.1% vs 81.8%) and accuracy (90.7% vs 88.4%).

68Ga-P15-041 PET/CT provides rapid imaging with high contrast and quantitative data, making it a promising routine procedure for detecting bone metastases in cancer patients, especially in settings where other radiotracers like 18F fluoride are unavailable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-P15-041, A Novel Bone Imaging Agent for Diagnosis of Bone Metastases. Guo, R., Meng, X., Wang, F., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 18 patients, high uptake of 68Ga PET imaging was associated with higher absorbed doses during 177Lu therapy for neuroendocrine tumors, indicating that 68Ga PET can help evaluate treatment suitability.

However, the correlation between 68Ga uptake and individual absorbed doses was limited, suggesting that while group-level predictions are possible, personalized dose planning may require additional methods beyond just 68Ga activity concentrations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationships between uptake of [68Ga]Ga-DOTA-TATE and absorbed dose in [177Lu]Lu-DOTA-TATE therapy. Stenvall, A., Gustafsson, J., Larsson, E., et al.[2022]

Gallium-68 Pentixafor PET/CT or PET/MRI is effective for imaging lymphomas, including those that do not respond well to traditional imaging methods like fluorine-18 FDG PET, particularly in cases like lymphoplasmacytic lymphoma and chronic lymphocytic leukemia.

This imaging technique shows higher uptake in certain types of lymphomas, such as mantle cell lymphoma and marginal zone lymphoma, making it a valuable tool for staging and evaluating treatment responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of [68Ga]Ga-Pentixafor PET/CT or PET/MRI in Lymphoma: A Systematic Review. Albano, D., Dondi, F., Bertagna, F., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9367619/

The Role of [68Ga]Ga-Pentixafor PET/CT or PET/MRI in ... The aim of this systematic review was to analyze the published data about the role of [68Ga]Ga-Pentixafor PET/CT or PET/MRI in lymphoma and to focus on ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40366789/

Head-to-Head Comparison of 68 Ga-PentixaFor PET/CT ... In a head-to-head comparison of diagnostic performance, 68Ga-PentixaFor PET/CT outperformed FDG PET/CT for hematologic malignancies, whereas FDG PET/CT ...

3. oncotarget.com oncotarget.com/article/7063/text/

[ 68 Ga]Pentixafor-PET/CT for imaging of chemokine ... This study investigated the feasibility of CXCR4-directed imaging of small cell lung cancer (SCLC) with positron emission tomography/computed tomography (PET/ ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2021-12214

[68Ga]-Pentixafor-PET/CT for the Imaging of Blood ... This trial aims to see whether [68Ga]-pentixafor works better than standard of care fluorodeoxyglucose ([18F]-FDG) in detecting and providing information about ...

5. ajronline.org ajronline.org/doi/10.2214/AJR.25.32708

Head-to-Head Comparison of 68 Ga-PentixaFor PET/CT and ... In conclusion, for evaluation of hematologic malignancies, 68Ga-PentixaFor PET/CT showed results superior to those of FDG PET/CT, including in multiple myeloma ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06834412

A Study Evaluating the Value of 68Ga-Pentixafor PET ... The aim is to To investigate whether 68Ga-pentixafor PET imaging can be used as a reliable complement to 18F-FDG PET imaging for clinical staging, treatment ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05093335

Study Details | NCT05093335 | In-Human CXCR4 Imaging ... 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 ...