Phase 2 Oesophageal Cancer Trial, Recruiting NCT06298916 Sponsor: Lantheus Medical Imaging Condition: Oesophageal Cancer
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Phase 2 Oesophageal Cancer Trial, Recruiting

NCT06298916
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

Part 1 (for patients with metastatic sarcoma):

  • You are 15 years old or older (if you are 15–17 years old, you must weigh at least 55 kg/121 lbs)
  • You have been diagnosed with a type of sarcoma (a soft tissue or bone cancer) that has spread to other parts of the body, confirmed by a lab test
  • Your tumor is suspected to have a specific protein on it called FAP (confirm with trial site)
  • You are willing to provide a stored tumor tissue sample, or have a new biopsy taken if no stored sample is available
  • Your kidneys are working well enough, based on a blood test
  • If you are a woman who could become pregnant, you have a negative pregnancy test, are not breastfeeding, and agree to use highly effective birth control during the study and for 28 days after your last dose
  • If you are a man who could father a child, you agree to use highly effective birth control, not donate sperm during the study, and for 28 days after your last dose

Part 2 (for patients with sarcoma or certain digestive system cancers due for surgery):

  • You are 15 years old or older (if you are 15–17 years old, you must weigh at least 55 kg/121 lbs)
  • You have been diagnosed with a sarcoma or a digestive system cancer (such as esophageal, stomach, pancreatic, or bowel cancer), confirmed by a lab test
  • Your tumor is suspected to have the FAP protein and you are already scheduled for surgery within 60 days (confirm with trial site)
  • You are willing to provide a tumor tissue sample taken during your planned surgery
  • Your kidneys are working well enough, based on a blood test
  • If you are a woman who could become pregnant, you have a negative pregnancy test, are not breastfeeding, and agree to use highly effective birth control during the study and for 28 days after your last dose
  • If you are a man who could father a child, you agree to use highly effective birth control, not donate sperm during the study, and for 28 days after your last dose

Who may not be able to join:

Part 1:

  • You are currently pregnant or breastfeeding
  • You have had a recent PET scan too close in time to the study scan (confirm specific timing with trial site)
  • You are currently taking part in another clinical trial
  • You have received cancer treatment in the 14 days before your study injection
  • You have had or plan to have a specific type of imaging scan (using a similar FAP-targeting agent) within 6 months before or after this trial
  • You have a history of, or currently have, a certain heart rhythm problem called QT prolongation, or you take medications known to cause this (confirm with trial site)
  • You have certain heart-related risk factors, such as heart failure, low potassium levels, or a family history of a heart condition called Long QT Syndrome
  • The trial doctor feels you are unlikely to follow the trial's requirements

Part 2:

  • Your cancer has spread to other parts of the body or cannot be removed by surgery
  • You have received cancer treatment in the 14 days before your study injection
  • You are currently pregnant or breastfeeding
  • You have had a recent PET scan too close in time to the study scan (confirm specific timing with trial site)
  • You are currently taking part in another clinical trial
  • You have had or plan to have a specific type of imaging scan (using a similar FAP-targeting agent) within 6 months before or after this trial
  • You have a history of, or currently have, a certain heart rhythm problem called QT prolongation, or you take medications known to cause this (confirm with trial site)
  • You have certain heart-related risk factors, such as heart failure, low potassium levels, or a family history of a heart condition called Long QT Syndrome
  • The trial doctor feels you are unlikely to follow the trial's requirements

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 978-671-8886

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Lantheus Medical Imaging
Registry
ClinicalTrials.gov
Start date
1 August 2025
Est. completion
1 November 2025

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Primary Part 1 Biodistribution of 64Cu-LNTH-1363S; Primary Part 1 - Optimal dose (radioactivity) and imaging time window of 64Cu-LNTH-1363S; Primary Part 2 - Correlation of 64Cu-LNTH-1363S biodistribution with Immunohistochemistry FAP expression

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov