Clinical trial Recruiting at 1 site Phase1; Phase2 Interventional Ages 18 and up

Imaging small cell lung cancer with a new tracer

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

Run by Memorial Sloan Kettering Cancer Center · NCT04199741 · Data updated 2026-11-12

This study is testing a new imaging agent to see if it can help doctors better see and identify small cell lung cancer and some related tumors in patients.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment105 (estimated)
SponsorMemorial Sloan Kettering Cancer Center
Academic / other
Locations1 site (New York, New York)
StatusRecruiting
StartedDecember 11, 2019
Main results expectedJune 11, 2027
Study endsJune 11, 2027
Registry record updatedOctober 27, 2026
Trial IDNCT04199741 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 or older with histologically confirmed small cell lung cancer or specific neuroendocrine tumors.

Probably not a fit

Patients with non-cancerous conditions or those who do not meet the eligibility criteria will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and processing of a novel imaging agent, 89Zr-DFO-SC16.56, in patients diagnosed with small cell lung cancer. It aims to determine how well this agent can visualize tumors using PET/CT imaging. The study includes both newly diagnosed and recurrent cases of small cell lung cancer, as well as certain neuroendocrine tumors. Participants will undergo imaging to assess the effectiveness of this tracer in identifying cancerous lesions.

Why it matters

Potential benefit: If successful, this study could improve the accuracy of imaging small cell lung cancer, leading to better diagnosis and treatment planning.

How similar studies have gone: Other studies using novel imaging agents for cancer detection have shown promising results, indicating potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion 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

Exclusion Criteria:

Subject Exclusion Criteria for the Adult population

* 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

Subject Exclusion Criteria for the Pediatric population

* 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

Where it's running

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

Study contacts

  • Principal investigator: Mark P Dunphy, DO — Memorial Sloan Kettering Cancer Center
  • Study coordinator: Mark P Dunphy, DO
  • Email: dunphym@mskcc.org
  • Phone: 212-639-8131

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.