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NCT05093335

In-Human CXCR4 Imaging of Hematologic and Solid Tumors Using [68Ga]-Pentixafor-PET

StatusActive, Not Recruiting
PhaseEarly Phase 1
Primary completion (estimated)
Track this trial

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Record History

All 19 versions: 13 with changes below, 6 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 10 words
    • Enrollment closed, study ongoing
    • Site details revised
  2. Trial status: Active, Not Recruiting to Recruiting
    • Primary and study completion dates: Oct 2026 to Oct 2027
    • Site details revised
    v18
  3. Collaborators shortened, about 2 wordsv17
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v16
  5. Primary and study completion dates: Oct 2025 to Oct 2026v14
Show 7 earlier versionsHide 7 earlier versions
  1. Site contact updatedv12
  2. Enrollment target: 20 to 30
    • Eligibility criteria expanded, about 24 words
    • Study title expanded, about 2 words
    v11
  3. Eligibility criteria expanded, about 14 wordsv9
  4. Site contact updatedv8
  5. Primary and study completion dates: Oct 2023 to Oct 2025
    • Collaborators expanded, about 2 words
    v6
  6. Eligibility criteria revisedv4
  7. Eligibility criteria expanded, about 15 wordsv3
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Tumor standard uptake value (SUV)
Timeframe: 1 year

Arms and interventions

[68Ga]-PentixaforExperimental

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.

Drugs: [68Ga]-Pentixafor

Sites

1 site in 1 country

  • Memorial Sloan Kettering Cancer CenterNew York, New York, United States