In-Human CXCR4 Imaging of Hematologic and Solid Tumors Using [68Ga]-Pentixafor-PET
NCT ID: NCT05093335
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
30 participants
INTERVENTIONAL
2021-10-01
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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[68Ga]-Pentixafor
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.
[68Ga]-Pentixafor
An intravenous bolus of 3 -5 mCi of \[68Ga\]-Pentixafor will be injected in all participants.
Interventions
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[68Ga]-Pentixafor
An intravenous bolus of 3 -5 mCi of \[68Ga\]-Pentixafor will be injected in all participants.
Eligibility Criteria
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Inclusion Criteria
* 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
* History of renal functional disorders (chronic kidney disease with eGFR\<30)
* Refusal or inability to tolerate the scanning procedure (e.g., due to claustrophobia)
18 Years
ALL
No
Sponsors
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Pentixapharm AG
INDUSTRY
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Anton Nosov, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Central Contacts
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Heiko Schoder, MD
Role: CONTACT
Phone: 212-639-2079
Facility Contacts
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Anton Nosov, MD
Role: primary
Heiko Schoder, MD
Role: backup
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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21-356
Identifier Type: -
Identifier Source: org_study_id