RecruitingPhase 1 / Phase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of 89Zr-DFO-SC16.56, a substance used for PET/CT imaging, and how the body processes it. It is mainly for adults with small cell lung cancer, but adults with certain other tumors and children age 4 or older with high-risk neuroblastoma may also join.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Give signed consent to join the study.
  • Adults must be 18 or older and have an eligible cancer: small cell cancer, a neuroendocrine tumor (a tumor of hormone-making cells), prostate cancer with suspected or confirmed neuroendocrine features, a confirmed or suspected brain tumor, or one of the other listed rare cancers.
  • Children must be age 4 or older and have high-risk neuroblastoma, a cancer that starts in young nerve cells.
  • Scans from the past 12 weeks must show a tumor at least 0.8 cm wide on CT or MRI, a tumor visible on another allowed scan, or new cancer spread to bone.
  • Have an ECOG activity score of 0–2, meaning you can be up and care for yourself for most of the day.
  • Children under 16 must also have a Lansky activity score of at least 40, a measure of their ability to play and be active.
  • If you could become pregnant, have a negative blood pregnancy test within 2 weeks before receiving the study substance.
  • Adults must have stored tumor tissue or a routine-care biopsy already planned to test for a protein called DLL3. If prostate cancer patients have no stored tissue, they must be willing to have a scan-guided biopsy, though the study doctor may waive it.

Who can't join

  • Have had anaphylaxis, a severe allergic reaction, to human or humanized antibodies.
  • Are pregnant or breastfeeding.
  • Have a mental health condition that would prevent you from following study steps.
  • Cannot have a PET scan because of the scanner's weight limit.
  • Need anesthesia or sedation with medical monitoring to tolerate the PET scan.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

NY