RecruitingPhase 1 / Phase 2NCT04199741
Official study titlePET/CT Imaging of Small Cell Lung Cancer Using 89Zr-DFO-SC16.56
Study summary
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.
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Key things to know
Main goalDiagnostic
This describes the study’s primary purpose.
What is being studied89Zr-DFO-SC16.56 and SC16.56, Phase I, Cohort 2
Plus 2 other study approaches.
Who it may be forSmall cell lung cancer (SCLC)
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Aug 12, 2026 · Source: ClinicalTrials.gov
Is enrollment open?Recruiting
The study is currently accepting participants.
What kind of study?Phase 1 / Phase 2
Interventional
Where is it offered?1 U.S. location
Locations may change over time.
Who runs it?Memorial Sloan Kettering Cancer Center
Study sponsor
Study overview
What this study is about
- Purpose
- Diagnostic
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Interventions being studied
- Drug: 89Zr-DFO-SC16.56; Drug: SC16.56, Phase I, Cohort 2; Drug: SC16.56, Phase I, Cohort 3; Drug: SC16.56, Phase II
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How this study is categorized
These labels come from structured fields and exact terms in the public record.
Cancer type
Public criteria
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
Requirements people may need to meetInclusion criteria
- Subject Inclusion Criteria for Adult population
- 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 OR Histologically confirmed or suspected primary brain neoplasm OR Desmoplastic small round cell tumors, osteosarcoma, Ewing's sarcoma, rabdomyosarcoma, Wilms tumors, hepatoblastomas, rhabdoid tumors and neuroblastoma patients
- At least one tumor lesion on CT2 or MRI ≥ 0.8 cm OR
- Tumor detectable FDG PET, PSMA PET, DOTATATE PET, MIBG SPECT (or planar MIBG scan if SPECT unavailable) OR
- MRI or bone scan that shows new osseous metastases. The scans should have been obtained in the last 12 weeks
- ECOG performance status 0 to 2
- Negative serum pregnancy test within 2 weeks of 89Zr-DFO-SC16.56 for women of child-bearing potential
- Available archival tumor specimen suitable for DLL3 IHC or clinician already has plans to obtain tumor specimen as part of standard of care (unrelated to patient participation in 19-292) which will yield sufficient tumor specimen to allow for DLL3 IHC
- For the prostate cancer patient cohort, as an alternative if archival tissue is not available, patients must be willing to undergo PET/CT guided biopsy3 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 itis not in the best interest of the patient, according to best clinical judgement. The pediatric population would not be approached for an optional PET/CT-guided biopsy Subject Inclusion Criteria for Pediatric population
- Signed, informed consent
- Age 4 or more years
- High risk neuroblastoma patients
- At least one tumor lesion on CT2 or MRI ≥ 0.8 cm OR Tumor detectable FDG PET, PSMA PET, DOTATATE PET, MIBG SPECT (or planar MIBG scan if SPECT unavailable) OR MRI or bone scan that shows new osseous metastases. The scans should have been obtained in the last 12 weeks
- ECOG performance status 0 to 2
- Performance Status: Subjects must have a Lansky (\<16 years) of at least 40
- Negative serum pregnancy test within 2 weeks of 89Zr-DFO-SC16.56 for women of child-bearing potential
Reasons someone may not be able to joinExclusion criteria
Subject
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
Study sites
U.S. locations
- Memorial Sloan Kettering Cancer CenterNew York, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 12, 2026. Always confirm current availability with the study team.