ClinicalTrials.gov record NCT05093335
In-Human CXCR4 Imaging of Hematologic and Solid Tumors Using [68Ga]-Pentixafor-PET
In-human CXCR4 Imaging of Hematologic and Solid Tumors Using [68Ga]-Pentixafor-PET
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This early-phase interventional diagnostic study gives an IV injection of [68Ga]-Pentixafor and performs PET/CT scans to measure tracer uptake in people with certain blood cancers, histiocytic neoplasms, and some solid tumors. Scans last about 1.5 hours; some participants may have two scans. The study records standardized uptake values and tumor-to-background ratios.
What it is studying. The study tests how well the imaging agent [68Ga]-Pentixafor is taken up by tumors that may express the CXCR4 target. It aims to measure tracer uptake levels and timing in tumors using PET/CT images (for example, standardized uptake values and tumor-to-background ratios) and to evaluate uptake dynamics.
What the researchers hope to learn. To measure and report tumor uptake (SUV and tumor-to-background ratios) and the uptake dynamics of [68Ga]-Pentixafor in the listed hematologic and selected solid tumors, to inform the agent's diagnostic performance.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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).
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- [68Ga]-Pentixafor
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Twenty patients with histologically proven treatment-naïve, therapy-refractory or relapsed blood cancers meeting the below criteria will be included:
- Indolent B- or T-cell Non-Hodgkin lymphoma (including cutaneous lymphomas) or Non-Hodgkin lymphoma with variable FDG uptake and clinical course, such as mantle cell lymphoma; and measurable disease according to Lugano criteria
- or
- Histiocytic neoplasms (Langerhans cell histiocytosis (LCH), Erdheim-Chester disease (ECD) and/or Rosai-Dorfman disease (RDD)
- MGUS/SMM or MM according to IMWG definitions
- Solid tumors, such as lung cancers, meningioma, adrenocortical neoplasms including cortisol-producing adenomas or high suspicion for tumor, such as in patients with Cushing's disease.
- Age ≥18
- Negative serum pregnancy test for female volunteers of childbearing age and potential (as defined by MSKCC Standards \& Guidelines) from assays obtained <2 weeks prior to study enrollment/intervention; or negative urine pregnancy test performed on the day of intervention
- MSKCC patients
Exclusion criteria
- Breast-feeding
- History of renal functional disorders (chronic kidney disease with eGFR<30)
- Refusal or inability to tolerate the scanning procedure (e.g., due to claustrophobia)
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants receive an intravenous injection of 3–5 mCi [68Ga]‑Pentixafor and undergo a PET/CT scan (low‑dose CT for attenuation correction). Scans take about 1.5 hours; some participants may have two scans. Female participants of childbearing potential will have pregnancy testing as required. Imaging may not be performed in cases of intolerance, dose or scanner availability, or other operational reasons.
How the study is structured. An early-phase, interventional diagnostic study with a single non-randomized group. Participants receive a single intravenous bolus of 3–5 mCi [68Ga]-Pentixafor and undergo PET/CT imaging (low-dose CT for attenuation correction). Imaging evaluates tracer uptake and pharmacokinetics; some people may have a second scan. There is no masking.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on Erdheim-Chester disease
Important dates
- Study start
- Oct 1, 2021
- Primary completion
- October 2027 (estimated)
- Study completion
- October 2027 (estimated)
- Target enrollment
- 30 participants (estimated)
- Last updated on registry
- Feb 5, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Anton Nosov, MD 📞 212-639-8575 ✉ nosova@mskcc.org
- Heiko Schoder, MD 📞 212-639-2079
Participating sites (1)
- Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, 10065 · United States
- Anton Nosov, MD · 212-639-8575
- Heiko Schoder, MD · 212-639-2079
Terms used on this page · explanations by MedicalUpdates.ai
- PET/CT
- A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
- treatment-naïve
- Has not previously received the treatment, or the type of treatment, that the study is about.
- refractory
- A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
- relapsed
- A condition that improved with treatment and has since returned or worsened.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- eGFR
- A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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