89Zr-DFO-SC16.56 PET/CT for the Diagnosis of Neuroendocrine Tumors
This phase I/II trial studies how well 89Zr-DFO-SC16.56 positron emission tomography (PET)/computed tomography (CT) works in diagnosing patients with neuroendocrine tumors. Scans with 89Zr-DFO-SC16.56 may be able to find tumors with large amounts of DLL3, helping doctors identify cancer patients who may benefit from new types of cancer-fighting drugs that target DLL3.
Inclusion Criteria
- ADULT POPULATION: Signed, informed consent
- ADULT POPULATION: Age 18 or more years
- ADULT POPULATION: 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, rhabdomyosarcoma, Wilms tumors, hepatoblastomas, rhabdoid tumors and neuroblastoma patients ** Patients with SCLC will be the primary study population, however patients with other types of neuroendocrine tumors may be included at the principal investigator's (PI’s) discretion
- ADULT POPULATION: At least one tumor lesion on CT** or magnetic resonance imaging (MRI) ≥ 0.8 cm OR * Tumor detectable fluorodeoxyglucose (FDG) PET, prostate specific membrane antigen (PSMA) PET, DOTATATE PET, metaiodobenzylguanidine (MIBG) single photon emission computed tomography (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 ** 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
- ADULT POPULATION: Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- ADULT POPULATION: Negative serum pregnancy test within 2 weeks of 89Zr-DFO-SC16.56 for women of child-bearing potential
- ADULT POPULATION: 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 biopsy** ** While willingness to undergo the biopsy is required if archival tissue is not available, PET/CT guided biopsy is not a mandatory study assessment. 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. The pediatric population would not be approached for an optional PET/CT-guided biopsy
- PEDIATRIC POPULATION: Signed, informed consent
- PEDIATRIC POPULATION: Age 4 or more years
- PEDIATRIC POPULATION: High risk neuroblastoma patients
- PEDIATRIC POPULATION: At least one tumor lesion on CT** 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 * 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
- PEDIATRIC POPULATION: ECOG performance status 0 to 2
- PEDIATRIC POPULATION: Performance Status: Subjects must have a Lansky (< 16 years) of at least 40
- PEDIATRIC POPULATION: Negative serum pregnancy test within 2 weeks of 89Zr-DFO-SC16.56 for women of child-bearing potential
Exclusion Criteria
- ADULT POPULATION: History of anaphylactic reaction to humanized or human antibodies
- ADULT POPULATION: Pregnant or breast feeding
- ADULT POPULATION: Psychiatric illness that would interfere with compliance with the study procedures
- ADULT POPULATION: Inability to undergo PET scan due to weight limit
- ADULT POPULATION: Patients who require anesthesia or monitored sedation to tolerate PET scan procedure
- PEDIATRIC POPULATION: History of anaphylactic reaction to humanized or human antibodies
- PEDIATRIC POPULATION: Pregnant or breast feeding
- PEDIATRIC POPULATION: Psychiatric illness that would interfere with compliance with the study procedures
- PEDIATRIC POPULATION: Inability to undergo PET scan due to weight limit
- PEDIATRIC POPULATION: Patients who require anesthesia or monitored sedation to tolerate PET scan procedure
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04199741.
Locations matching your search criteria
United States
New York
New York
PRIMARY OBJECTIVES:
I. To study the pharmacokinetics, metabolism, biodistribution and radiation dosimetry and safety of zirconium Zr 89-DFO-SC16.56 (89Zr-DFO-SC16.56) PET/CT imaging in cancer patients. (Phase I)
II. To determine the correlation between tumor uptake of 89Zr-DFO-SC16.56 with expression of DLL3 as determined by immunohistochemistry and quantitative mass spectrometry. (Phase II)
SECONDARY OBJECTIVES:
I. To determine the feasibility of 89Zr-DFO-SC16.56 PET/CT imaging of DLL3 expression in small cell lung cancer (SCLC). (Phase I)
II. To identify a suitable antibody mass of 89Zr-DFO-SC16.56 for PET/CT imaging. (Phase I)
III. To identify a suitable time between injection of 89Zr-DFO-SC16.56 and PET imaging. (Phase I)
EXPLORATORY OBJECTIVES:
I. To obtain preliminary data on the intra- and inter-patient heterogeneity 89Zr-DFO-SC16.56. (Phase II)
II. To explore DLL3 PET-guided tumor biopsy in a cohort of prostate cancer patients with suspected or confirmed tumor transformation to neuroendocrine prostate carcinoma. (Phase II)
III. Evaluate changes in biodistribution of 89Zr-DFO-SC16.56 in patients receiving DLL3 directed therapy. (Phase II)
OUTLINE: Patients are assigned to 1 of 2 phases (NOTE: Pediatric patients are assigned to Phase II).
PHASE I: Patients receive 89Zr-DFO-SC16.56 intravenously (IV) over 5-10 minutes and undergo up to 4 PET/CT scans over 56 minutes at 1-4 hours, 1-2 days, 3-5 days, and 6-8 days post-injection. Additionally, patients undergo blood sample collection throughout the study.
PHASE II: Patients receive 89Zr-DFO-SC16.56 as in Phase I and undergo only one PET/CT scan over 56 minutes 3-5 days post-injection. Patients with prostate cancer and positive expression also undergo PET/CT-guided biopsy within 8 days. Additionally, patients undergo blood sample collection throughout the study. NOTE: Pediatric patients receive a lower dose of 89Zr-DFO-SC16.56 and undergo only one low-dose PET/CT scan.
After completion of study, patients are followed up at 14 days after 89Zr-DFO-SC16.56 injection.
Trial PhasePhase I/II
Trial Typediagnostic
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorMark Dunphy
- Primary ID19-292
- Secondary IDsNCI-2019-08657
- ClinicalTrials.gov IDNCT04199741