PET/CT Imaging of Small Cell Lung Cancer Using 89Zr-DFO-SC16.56

Description

The purpose of this study is to look at how safe 89Zr-DFO-SC16.56 is, and how it is processed by the body in people with small cell lung cancer.

Conditions

Small Cell Lung Cancer, Small Cell Lung Carcinoma

Study Overview

Study Details

Study overview

The purpose of this study is to look at how safe 89Zr-DFO-SC16.56 is, and how it is processed by the body in people with small cell lung cancer.

Immuno-PET Imaging of Neuroendocrine Tumors Using 89Zr-DFO-SC16.56, a DLL3-targeting Monoclonal Antibody

PET/CT Imaging of Small Cell Lung Cancer Using 89Zr-DFO-SC16.56

Condition
Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

New York

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Signed, informed consent
  • * Age 18 or more years
  • * Histologically confirmed, SCLC, (newly diagnosed or recurrent); small cell carcinoma of unknown or non-lung origin; or other types of neuroendocrine tumor OR
  • * Histologically confirmed prostate cancer, with suspected or confirmed NEPC based upon clinical assays obtained prior to the trial
  • * At least one tumor lesion on CT or MRI \>/= 2 cm
  • * ECOG performance status 0 to 2
  • * Negative serum pregnancy test within 2 weeks of 89Zr- DFO-SC16.56 or women of child-bearing potential
  • * Adequate organ function as assessed by
  • * Absolute neutrophil count (ANC) \>/= 1,500 mm\^8
  • * Hemoglobin \>/= 8.0 g/dL
  • * Platelet count \>/= 75,000/mm\^3
  • * Bilirubin \</= 1.5 x ULN (upper limit of the norm)
  • * AST (GOT) \</= 3.0 x ULN (when no liver metastases are present)
  • * AST (GOT) \</= 5.0 x ULN (when liver metastases are present)
  • * ALT (GOT) \</= 3.0 x ULN (when no liver metastases are present)
  • * ALT (GOT) \</= 5.0 x ULN (when no liver metastases are present)
  • * Creatinine \</= 1.5 x ULN
  • * Available archival tumor biopsy material suitable for DLL3 IHC. Archival tissue is not required to have been collected within a specific time frame relative to imaging
  • * For the prostate cancer patient cohort, as an alternative if archival tissue is not available, patients must be willing to undergo PET/CT guided biopsy\*\* as described in section 9.3.
  • 1. Patients with SCLC will be the primary study population, however patients with other types of neuroendocrine tumors may be included at the PI's discretion.
  • 2. Criterion is intended to demonstrate presence of imageable disease. A low-dose CT (e.g. from a PET/CT scan) may be used at PI's discretion
  • 3. While willingness to undergo the biopsy is required if archival tissue is not available, PET/CT guided biopsy is not a mandatory study assessment. As described in section 9.3, the guided biopsy may be waived at the discretion of the principal investigator if the DLL3 PET/CT reveals no sites of DLL3 tracer-avid tumor or if the principal investigator deems it is not in the best interest of the patient, according to best clinical judgement.
  • * History of anaphylactic reaction to humanize or human antibodies
  • * Pregnant or breast feeding
  • * Psychiatric illness that would interfere with compliance with the study procedures
  • * Inability to undergo PET scan due to weight limit

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Memorial Sloan Kettering Cancer Center,

Mark P Dunphy, DO, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

2026-06-11