[89Zr]DFO-YS5 for Cancer Detection
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new imaging method for detecting certain types of cancer, including nerve sheath tumors, bladder cancer, and advanced solid tumors. The study administers a special compound called [89Zr]DFO-YS5 through an IV and tracks its movement in the body with a PET scan. This method could help doctors see tumors more clearly. People with these cancers who can undergo a PET scan might be suitable for the trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new imaging method.
What prior data suggests that this radiotracer is safe for cancer detection?
A previous study used [89Zr]DFO-YS5 to detect prostate cancer and showed promise in identifying cancerous tissues. However, some participants experienced gradual weight loss, suggesting that while the treatment may be effective for imaging, it could have side effects related to weight.
[89Zr]DFO-YS5 remains in the early stages of testing, so researchers are still gathering safety information, and all possible side effects are not yet known. Early testing is crucial to confirm if a treatment is safe and tolerable before wider use. Researchers will closely monitor participants in this trial for any negative effects to ensure their safety.12345Why are researchers excited about this trial?
Researchers are excited about [89Zr]DFO-YS5 because it offers a novel approach to cancer detection using a targeted imaging technique. Unlike traditional methods that often rely on broad imaging or biopsies, [89Zr]DFO-YS5 uses a radiolabeled compound that specifically binds to cancer cells, allowing for precise whole-body PET imaging. This approach not only aims to improve the accuracy of cancer detection but also has the potential to identify cancerous activity earlier, enhancing treatment planning and outcomes.
What evidence suggests that [89Zr]DFO-YS5 is effective for cancer detection?
Research has shown that the radiotracer [89Zr]DFO-YS5 effectively detects tumors in various cancer types. Studies have found that it can identify small tumors in the liver, kidneys, and lungs using PET scans, which make cancer cells visible. In prostate cancer models, [89Zr]DFO-YS5 reliably attaches to cancer cells, aiding doctors in locating the cancer within the body. In this trial, participants will receive a single intravenous microdose of [89Zr]DFO-YS5, followed by whole-body PET imaging. While primarily used for imaging, its tumor detection capability could enhance diagnosis and treatment planning.678910
Who Is on the Research Team?
Robert Flavell, MD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for people with nerve sheath tumors, bladder cancer, or advanced solid tumors. Participants must have one of these cancers and be able to undergo imaging scans. Specific inclusion and exclusion criteria are not detailed here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intravenous microdose of [89Zr]DFO-YS5 followed by whole-body PET imaging conducted 120-168 hours after administration
Follow-up
Participants are monitored for treatment-emergent adverse events
What Are the Treatments Tested in This Trial?
Interventions
- [89Zr]DFO-YS5
Trial Overview
The study tests a new imaging agent called [89Zr]DFO-YS5 used in PET/CT or PET/MRI scans to help detect certain cancers. It is an early-stage (pilot) study at a single center.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will be administered a single, intravenous microdose (1.0 - 3.0 mCi) of \[89Zr\]DFO-YS5, followed by whole-body positron emission tomography (PET) imaging conducted 120-168 hours after \[89Zr\]DFO-YS5 administration (i.e., on Day 6-8). Participants will be followed for treatment-emergent adverse events for up to 35 days.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Robert Flavell, MD, PhD
Lead Sponsor
Kyntra Bio
Industry Sponsor
Fortis Therapeutics, Inc.
Industry Sponsor
Citations
Jun Li from Central South University
Conclusions:[89Zr]DFO-YS5 is an excellent PET imaging agent across a panel of prostate cancer models, including in both adenocarcinoma and neuroendocrine ...
2.
researchgate.net
researchgate.net/publication/369181439_CD46_targeted_212Pb_alpha_particle_radioimmunotherapy_for_prostate_cancer_treatment(PDF) CD46 targeted 212Pb alpha particle ...
CMC-YS5 was well tolerated and caused potent and sustained inhibition of established tumors, 89 Zr]DFO-YS5 enables immuno-PET imaging
3.
aacrjournals.org
aacrjournals.org/clincancerres/article-pdf/doi/10.1158/1078-0432.CCR-24-2850/3541846/ccr-24-2850.pdfEffective Treatment of Disseminated Prostate Cancer Using ...
Microtumor lesions, primarily observed in the liver, kidneys, and lungs, were successfully 87 detected with [89Zr]DFO-YS5 PET imaging.
FibroGen Announces Presentation of Positive Interim Data ...
bone as FG-3246 (89Zr-DFO-YS5) was obtained in a subset of patients and demonstrated tumor uptake in multiple lesions. 89Zr-DFO-YS5 as a ...
[225Ac]Macropa-PEG4-YS5 - Drug Targets, Indications, Patents
Microtumor lesions, primarily observed in the liver, kidneys, and lungs, were successfully detected with [89Zr]DFO-YS5 PET imaging. We used disseminated ...
Current landscape and clinical progress of targeted alpha ...
YS5 was first labeled with 89Zr, and demonstrated prostate cancer detection in vivo, exhibited gradual decrease in body weights. Three ...
Effective imaging and treatment of Acute Myeloid Leukemia ...
Moreover, [89Zr]DFO*-7065 demonstrated higher tumor uptake and improved tumor to background ratios compared to the standard of care [18F]-FDG.
8.
synapse.patsnap.com
synapse.patsnap.com/blog/indication-strategy-report-malignant-peripheral-nerve-sheath-tumor-2026-mcpMalignant peripheral nerve sheath tumor Indication...
Malignant peripheral nerve sheath tumor is the sole indication evaluated in this 2026 strategy report. The analysis connects disease context, epidemiology, ...
9.
researchgate.net
researchgate.net/publication/332923433_PETCT_Imaging_of_Human_TNFa_Using_89ZrCertolizumab_Pegol_in_a_Transgenic_Preclinical_Model_of_Rheumatoid_Arthritis?_share=1PET/CT Imaging of Human TNFα Using [89Zr]Certolizumab ...
[89Zr]DFO-CZP was isolated with radiolabeling yields of 85 ± 6 % (n = 5) and specific activities ranging from 74 to 185 MBq/mg (n = 5).
Radionuclides Landscape in Prostate Cancer Theranostics
89Zr, and 125I are presented, em- phasizing their clinical implementation … survival outcomes have been limited, it identified lesions in up to ...
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