PET Imaging of Solid Tumors Using 124I-Humanized 3F8: A Pilot Study

December 2, 2025 updated by: Memorial Sloan Kettering Cancer Center
The purpose of this study is to find out how an antibody called Hu3F8 travels through the body and to tumors. Antibodies, like Hu3F8, are proteins that help attack tumors or fight infections. Antibodies can be made by your own body or in a laboratory. The target of an antibody is called an antigen; antibodies fit their antigen like a lock fits a key.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with the diagnosis of neuroblastoma must meet both of the following criteria:

    • Diagnosis confirmed by histological assessment by MSKCC Department of pathology or by the presence of BM metastases PLUS elevated urinary catecholamines
    • Relapsed or refractory stage 4 disease or relapsed or refractory stage MYCN-amplified 2B or 3 disease.
    • Patients with tumors other than neuroblastoma must meet both the following criteria:
    • Have one of the following diagnoses (these tumors are known to express GD2 on cell surface):
    • Melanoma
    • Osteogenic sarcoma
    • Leiomyosarcoma
    • Ewing sarcoma
    • Liposarcoma
    • Fibrosarcoma
    • Malignant fibrous histiocytoma
    • Spindle cell sarcoma
    • Small cell lung cancer
    • Medulloblastoma metastatic to extracranial sites
    • Paraganglioma
    • Have refractory or relapsed or metastatic disease
    • Patients with solid tumors with diagnoses OTHER than neuroblastoma or those listed above will be eligible if they meet both of the following criteria:
    • Immunohistochemical demonstration of GD2 expression on cell surface (Tumor assessment by immunohistochemistry is required for this group of patients)
    • Have refractory or relapsed disease or metastatic disease. All patients must have measurable or evaluable disease
    • Age 3-90 years
    • Prior treatment with anti-GD2 monoclonal antibody is permitted only if human anti-human antibody titer is ≤1300 assay developed by Dr. Nai-Kong Cheung.
    • Negative serum pregnancy test in women of childbearing potential
    • Women of child-bearing potential must be willing to practice an effective method of birth control while on study
    • Signed informed consent indicating awareness of the investigational nature of this study.

Exclusion Criteria:

  • Existing major organ dysfunction > grade 2, with the exception of myelosuppression (neutrophil count > or = 500/μl and platelet count > or = 25,000/μl are acceptable) and hearing loss.

    • Acute life threatening infection
    • Requirement for sedation for PET/CT scans
    • Pregnant women or women who are breast-feeding.
    • Inability to comply with protocol requirements.
    • Hypersensitivity to potassium iodide or Lugols products
    • Prior development of positive human antimouse antibody response (HAMA) or human antihuman antibody response (HAHA)
    • Positive human anti-hu3F8 antibody titer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PET Imaging using 124I-Humanized 3F8
124I-hu3F8 at a dose of 3mCi/m2 (with a maximum dose of 5mCi) will be injected IV. 124I-hu3F8 PET/CT scans will be performed at approximately 2-4 hours, 18-26hours, 48-72 hours and 96-144 hours after injection of 124I-hu3F8. A low dose CT scan will be obtained with each PET scans. PET/CT scan images will be analyzed to determine biodistribution of 124I-hu3F8 and to determine dosimetry to organs and sites of disease. Comparison of tumor targeting and tumor dosimetry will be made between the two cohorts of patients: (a) NB and (b) other solid tumors. Blood will be drawn where feasible at multiple time points: approximately 0h, 0.5h, 1h, 2h, 4-8h, 24h, 48h, 96h and 120h-144h after injection of 124I-hu3F8 and radioactivity measured to determine pharmacokinetics of 124I-hu3F8.
Biological: 124I-Humanized 3F8

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
radioactivity measured to determine pharmacokinetics of 124I-hu3F8
Time Frame: 2 years
Following 124I-hu3F8 administration, upon completion of normal saline flush, blood will be drawn for pharmacokinetic studies at the following time points: 0h, 0.5h, 1h, 2h, 4-8h, 24h, 48h, 96h and 120-144 h.after injection of 124I-hu3F8 and radioactivity measured to determine pharmacokinetics of 124I-hu3F8.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PET/CT scan images will be analyzed to determine bio distribution of 124I-hu3F8
Time Frame: 2 years
124I-hu3F8 will be injected IV followed by PET/CT scans at serial timepoints PET/CT scan images will be analyzed to determine biodistribution of 124I-hu3F8
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Y-mAbs Therapeutics

Investigators

  • Principal Investigator: Shakeel Modak, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

November 20, 2014

First Submitted That Met QC Criteria

December 1, 2014

First Posted (Estimated)

December 4, 2014

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-147

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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