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PET/CT Imaging for Small Cell Lung Cancer with 89Zr-DFO-SC16.56

This study is looking at a new imaging agent called 89Zr-DFO-SC16.56 to see how safe it is and how your body processes it. This agent is used with PET/CT scans to help doctors see small cell lung cancer (SCLC) and other neuroendocrine tumors. The study aims to understand the radiation dose from 89Zr-DFO-SC16.56 and check for any side effects. It also wants to see if the imaging agent's uptake in tumors matches a specific protein called DLL3. You may be able to join if you are 18 or older and have confirmed SCLC or certain other neuroendocrine tumors. The study plans to enroll 53 participants.

Study design
This is an interventional study with no specified phase, meaning participants will receive a study intervention. It plans to enroll 53 participants.
What's involved
Participants in Phase I will receive an injection of 2 mCi of 89Zr-DFO-SC16.56. Some participants in Phase I will also receive 7.5mg or 22.5mg of SC16.56.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 12 months to assess radiation dosimetry, safety, and tumor uptake correlation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04199741

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

Recruiting
PHASE1Ages 18+InterventionalDiagnostic
Memorial Sloan Kettering Cancer Center
~105 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:89Zr-DFO-SC16.56SC16.56, Phase I, Cohort 2SC16.56, Phase I, Cohort 3SC16.56, Phase II

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase I: Radiation Dosimetry of 89Zr- DFO-SC16.56 PET/CT imaging in participants
Measured over Up to 12 months
+2 more outcomes measured

Conditions

Small Cell Lung Cancer
Small Cell Lung Carcinoma

Explore related trials

Brain NeoplasmDesmoplastic Small Round Cell TumorEwing SarcomaHepatoblastomaLung Small Cell CarcinomaNeuroblastomaNeuroendocrine TumorOsteosarcomaProstate CarcinomaRhabdoid TumorRhabdomyosarcomaSmall Cell Neuroendocrine CarcinomaWilms TumorDLL3 Gene

Where it's being run

1 sites across 1 states
New York1

Study leadership

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

Who to contact

Mark P Dunphy, DO
[email protected]
212-639-8131
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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

Exclusion

History of anaphylactic reaction to humanized 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
Patients who require anesthesia or monitored sedation to tolerate PET scan procedure
History of anaphylactic reaction to humanized 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
Patients who require anesthesia or monitored sedation to tolerate PET scan procedure

What this trial measures

  • Phase I: Radiation Dosimetry of 89Zr- DFO-SC16.56 PET/CT imaging in participantsUp to 12 months

    The PET and blood data are used to quantify tracer-biodistribution, measuring the amount of radioactivity present in the blood and bodily regions-of-interest

  • Phase I: Safety of 89Zr- DFO-SC16.56 PET/CT imaging in cancer patients by evaluating toxicitiesup to 12 months

    89Zr- DFO-SC16.56 PET/CT will be considered safe if there are no possibly probably, or definitely related grade 3 or higher toxicities (except allergic reactions) among the patients enrolled in the phase I portion

  • Phase II: Correlation between tumor uptake of 89Zr- DFO-SC16.56 with expression of DLL3Up to 12 months

    This is determined by immunohistochemistry and quantitative mass spectrometry.