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RECRUITING Phase 1

64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer

NCT06298916 · View on ClinicalTrials.gov ↗

Study Summary

This is a multicenter, open-label, prospective Phase 1/2a study to assess safety and tolerability, establish dosimetry and to identify an optimal imaging dose (radioactivity) and imaging time window of 64Cu-LNTH-1363S, and to compare its imaging biodistribution with FAP expression by IHC in patients with sarcomas or GIT cancers. The study will be conducted in 2 parts (Part 1 and Part 2).

Interventions

  • COMBINATION_PRODUCT 64Cu-LNTH-1363S

Study Locations (5)

California

  • City of Hope — Duarte
  • UC Irvine Health - Chao Family Comprehensive Cancer Center — Orange
  • Stanford Hospital & Clinics — Stanford

Michigan

  • BAMF Health, Inc. — Grand Rapids

Ohio

  • Cincinnati Children's Hospital Medical Center — Cincinnati

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2025-08
Est. Completion 2026-04
Phase Phase 1

Sponsor

Lantheus Medical Imaging

32 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06298916

The ClinicalTrials.gov registry entry for NCT06298916 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lantheus Medical Imaging, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 6 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 1 intervention — of which 64Cu-LNTH-1363S is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06298916 reports 5 study locations spanning 3 distinct geographic areas — top geographies include California, Michigan, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06298916 about?

NCT06298916 is a clinical study titled "64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer". This is a multicenter, open-label, prospective Phase 1/2a study to assess safety and tolerability, establish dosimetry and to identify an optimal imaging dose (radioactivity) and imaging time window of 64Cu-LNTH-1363S, and to compare its imaging biodistribution with FAP expression by IHC in patients...

What is the current status of trial NCT06298916?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2025-08. Estimated completion is 2026-04.

What conditions does trial NCT06298916 study?

This clinical trial studies the following conditions: Colorectal Cancer, Pancreatic Cancer, Gastric Cancer, Esophageal Cancer, Sarcoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06298916?

The interventions under investigation include: 64Cu-LNTH-1363S (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06298916?

This trial is sponsored by Lantheus Medical Imaging, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06298916 being conducted?

This trial has 5 study locations across California, Michigan, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial