Imaging small cell lung cancer with a new tracer
Immuno-PET Imaging of Neuroendocrine Tumors Using 89Zr-DFO-SC16.56, a DLL3-targeting Monoclonal Antibody
This study is testing a new imaging agent to see if it can help doctors better see and identify small cell lung cancer and some related tumors in patients.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 53 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04199741 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and processing of a novel imaging agent, 89Zr-DFO-SC16.56, in patients diagnosed with small cell lung cancer. It aims to determine how well this agent can visualize tumors using PET/CT imaging. The study includes both newly diagnosed and recurrent cases of small cell lung cancer, as well as certain neuroendocrine tumors. Participants will undergo imaging to assess the effectiveness of this tracer in identifying cancerous lesions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older with histologically confirmed small cell lung cancer or specific neuroendocrine tumors.
Not a fit: Patients with non-cancerous conditions or those who do not meet the eligibility criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of imaging small cell lung cancer, leading to better diagnosis and treatment planning.
How similar studies have performed: Other studies using novel imaging agents for cancer detection have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Signed, informed consent
* Age 4 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
* 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
* 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 or 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 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, a bone scan that shows new osseous metastases, or have recent PET or SPECT scans that demonstrate tumors that are evaluable by PET or SPECT. The scans should have been obtained in the last 8 weeks.
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. The pediatric population would not be approached for an optional PET/CT-guided biopsy
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
* Patients who require anesthesia or monitored sedation to tolerate PET scan procedure
Where this trial is running
New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Mark P Dunphy, DO — Memorial Sloan Kettering Cancer Center
- Study coordinator: Mark P Dunphy, DO
- Email: dunphym@mskcc.org
- Phone: 212-639-8131
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.