64Cu-LNTH-1363S for Sarcoma or Gastrointestinal Cancers
This study is testing a new imaging agent called 64Cu-LNTH-1363S in people with metastatic sarcoma, or esophageal, gastric, pancreatic, or colorectal cancer. This agent is designed to help doctors see certain cancer cells better using PET/CT scans. The study aims to find the best dose and timing for these scans, and to see how well the imaging results match what is found in tissue samples. The study is currently recruiting up to 26 participants, but its overall status is unclear.
- Study design
- This is an open-label study, meaning you and your doctors will know which intervention you are receiving. It plans to enroll 26 participants.
- What's involved
- If you participate, you would have a screening period of up to 14 days, a single day for the intervention, and a safety follow-up period of 7 days after the dose.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants in Part 1 will have a safety follow-up period of 7 days after receiving the dose. For Part 2, follow-up continues until the end of the study after tissue collection.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer
At a glance
Conditions
Where it's being run
5 sites across 3 statesWho to contact
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What this trial measures
- Primary Part 1 Biodistribution of 64Cu-LNTH-1363SDuring serial PET/CT scans taken on Day 1 at the following timepoints at 0.5 hour ± 10 minutes, 1 hour ±10 minutes, 2 hours ± 15 minutes, 4 to 6 hours, and 24 hours ± 4 hours post study intervention administration.
Time Activity Curves (TACs) describing percentage of the injected activity versus time will be derived for selected organs and tumor lesions and absorbed radiation doses of 64Cu-LNTH-1363S in critical organs (e.g., kidneys, liver) will be estimated.
- Primary Part 1 - Optimal dose (radioactivity) and imaging time window of 64Cu-LNTH-1363SDuring serial PET/CT scans taken on Day 1 at the following timepoints at 0.5 hour ± 10 minutes, 1 hour ±10 minutes, 2 hours ± 15 minutes, 4 to 6 hours, and 24 hours ± 4 hours post study intervention administration.
Optimal dose (radioactivity) and imaging time window will be determined by using image quality scores from blinded central reviews. Each patient will receive 8 ± 1 mCi of 64Cu-LNTH-1363S. The raw data of each patient PET scan will be re-processed using a computer program to simulate scans of the same patient with lower injected activities (6 mCi and 4 mCi).
- Primary Part 2 - Correlation of 64Cu-LNTH-1363S biodistribution with Immunohistochemistry FAP expressionPost surgery tissue collection to end of study
Correlation of 64Cu-LNTH-1363S biodistribution with FAP expression by IHC (SUVmean and SUVmax vs IHC score) and compare to circulating FAP in blood as analyzed by ELISA method.