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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05093335
Other study ID # 21-356
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date October 1, 2021
Est. completion date October 2025

Study information

Verified date April 2024
Source Memorial Sloan Kettering Cancer Center
Contact Simone Krebs, MD
Phone 212-639-7998
Email krebss@mskcc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date October 2025
Est. primary completion date October 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 - 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 Design


Intervention

Drug:
[68Ga]-Pentixafor
An intravenous bolus of 4.1 mCi (150 MBq) ± 10% of [68Ga]-Pentixafor will be injected in all participants.

Locations

Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (2)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center Pentixapharm AG

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tumor standard uptake value (SUV) Means and 95% confidence intervals for [68Ga]-Pentixafor standardized uptake values (SUV) and tumor-to-background ratios (TBR) of tumors will be recorded. Uptake will be measured in tumors. 1 year
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