Lung Cancer Clinical Trial
PET/CT Imaging of Small Cell Lung Cancer Using 89Zr-DFO-SC16.56
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.
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) = 2.5 x ULN (when no liver metastases are present)
AST (GOT) = 5.0 x ULN (when liver metastases are present)
ALT (GOT) = 2.5 x ULN (when no liver metastases are present)
ALT (GOT) = 5.0 x ULN (when 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.
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.
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
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There is 1 Location for this study
New York New York, 10065, United States More Info
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