Small Cell Lung Cancer study: 89Zr-DFO-SC16.56 vs SC16.56
Official title PET/CT Imaging of Small Cell Lung Cancer Using 89Zr-DFO-SC16.56
ClinicalTrials.gov ID: NCT04199741
What this study is testing
What is 89Zr-DFO-SC16.56?
an investigational injectable agent being studied for safety and behavior in people with small cell lung cancer
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to determine how safe the tracer is and how it is processed by the body in patients with small cell lung cancer.
- Who it's for
- Adults diagnosed with small cell lung cancer.
- What's involved
- Participants will receive a PET/CT scan using the 89Zr‑DFO‑SC16.56 tracer and may have additional blood tests or imaging as needed.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject for Adult population
- Signed, informed consent
- Age 18 or more years
- Histologically confirmed, SCLC, (newly diagnosed or recurrent); small cell carcinoma of unknown or non-lung origin
- At least one tumor lesion on CT2 or MRI ≥ 0.8 cm OR
You likely can't join if
- Subject Exclusion Criteria for the Adult population
- History of anaphylactic reaction to humanized 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 Subject Exclusion Criteria for the Pediatric population
See the full eligibility criteria
- Subject for Adult population
- Signed, informed consent
- Age 18 or more years
- Histologically confirmed, SCLC, (newly diagnosed or recurrent); small cell carcinoma of unknown or non-lung origin
- 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
- Negative serum pregnancy test within 2 weeks of 89Zr-DFO-SC16.56 for 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...
- For the prostate cancer patient cohort, as an alternative if archival tissue is not available, patients must be willing to undergo PET/CT guided biopsy3 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.
- 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.
- While willingness to undergo the biopsy is required if archival tissue is not available, PET/CT guided biopsy is not a mandatory study assessment.
- Signed, informed consent
- Age 4 or more years
- High risk 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.
- ECOG performance status 0 to 2
- Performance Status: people must have a Lansky (\<16 years) of at least 40
- Negative serum pregnancy test within 2 weeks of 89Zr-DFO-SC16.56 for women of child-bearing potential
- Subject Exclusion Criteria for the Adult population
- History of anaphylactic reaction to humanized 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 Subject Exclusion Criteria for the Pediatric population
- History of anaphylactic reaction to humanized 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
The study team makes the final eligibility decision.
Where it is enrolling
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.