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

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Dec 12, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging technique called 89Zr-DFO-SC16.56 to see how safe it is and how the body processes it in people with small cell lung cancer, a type of lung cancer that can be aggressive. The researchers want to learn more about this method and how well it helps to visualize cancer in the body using a type of scan called PET/CT.

To participate, you need to be at least 18 years old and have a confirmed diagnosis of small cell lung cancer or certain other types of cancer. You'll also need to have at least one tumor that is 2 cm or larger. If you join the trial, you will undergo some tests and imaging procedures to track how the new method works for you. It's important to note that women who can become pregnant must have a negative pregnancy test before participating. Overall, this trial aims to improve how we detect and understand small cell lung cancer, which could lead to better treatment options in the future.

Gender

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Eligibility criteria

• Inclusion 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
• • ° For the prostate cancer patient cohort with only bone metastases, a recent PET scan (FDG or PSMA-targeted) that shows tracer-avid osseous metastases, a recent MRI that shows new osseous metastases, or a bone scan that shows new osseous metastases. The scans should have been obtained in the last 8 weeks.
• • 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.
• Exclusion Criteria:
• • 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