RECRUITING

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

Conditions

Small Cell Lung Cancer Small Cell Lung Carcinoma 89Zr-DFO-SC16.56 19-292 Memorial Sloan Kettering Cancer Center

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-12-11

Study Completion:2026-06-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04199741

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 * At least one tumor lesion on CT or MRI \>/= 2 cm * ECOG performance status 0 to 2 * Negative serum pregnancy test within 2 weeks of 89Zr- DFO-SC16.56 or women of child-bearing potential * Adequate organ function as assessed by * Absolute neutrophil count (ANC) \>/= 1,500 mm\^8 * Hemoglobin \>/= 8.0 g/dL * Platelet count \>/= 75,000/mm\^3 * Bilirubin \</= 1.5 x ULN (upper limit of the norm) * AST (GOT) \</= 3.0 x ULN (when no liver metastases are present) * AST (GOT) \</= 5.0 x ULN (when liver metastases are present) * ALT (GOT) \</= 3.0 x ULN (when no liver metastases are present) * ALT (GOT) \</= 5.0 x ULN (when no liver metastases are present) * Creatinine \</= 1.5 x ULN * Available archival tumor biopsy material suitable for DLL3 IHC. Archival tissue is not required to have been collected within a specific time frame relative to imaging * 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\\ 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 it is not in the best interest of the patient, according to best clinical judgement.	* History of anaphylactic reaction to humanize 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

Inclusion Criteria

Exclusion Criteria

* 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
* At least one tumor lesion on CT or MRI \>/= 2 cm
* ECOG performance status 0 to 2
* Negative serum pregnancy test within 2 weeks of 89Zr- DFO-SC16.56 or women of child-bearing potential
* Adequate organ function as assessed by
* Absolute neutrophil count (ANC) \>/= 1,500 mm\^8
* Hemoglobin \>/= 8.0 g/dL
* Platelet count \>/= 75,000/mm\^3
* Bilirubin \</= 1.5 x ULN (upper limit of the norm)
* AST (GOT) \</= 3.0 x ULN (when no liver metastases are present)
* AST (GOT) \</= 5.0 x ULN (when liver metastases are present)
* ALT (GOT) \</= 3.0 x ULN (when no liver metastases are present)
* ALT (GOT) \</= 5.0 x ULN (when no liver metastases are present)
* Creatinine \</= 1.5 x ULN
* Available archival tumor biopsy material suitable for DLL3 IHC. Archival tissue is not required to have been collected within a specific time frame relative to imaging
* 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\*\* 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 it is not in the best interest of the patient, according to best clinical judgement.

* History of anaphylactic reaction to humanize 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

Contacts and Locations

Study Contact

Mark P Dunphy, DO

CONTACT

212-639-8131

dunphym@mskcc.org

Charles Rudin, MD, PhD

CONTACT

646-888-4527

rudinc@mskcc.org

Principal Investigator

Mark P Dunphy, DO

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-11

Study Completion Date2026-06-11

Study Record Updates

Study Start Date2019-12-11

Study Completion Date2026-06-11

Terms related to this study

Keywords Provided by Researchers

Small cell lung cancer
Small Cell Lung Carcinoma
89Zr-DFO-SC16.56
19-292
Memorial Sloan Kettering Cancer Center

Additional Relevant MeSH Terms

Small Cell Lung Cancer
Small Cell Lung Carcinoma