Actively Recruiting
A Phase 1/2a Study Utilizing 64Cu-LNTH-1363S (64Cu Radiolabeled FAPi PET/CT Imaging Agent) in Patients With Sarcoma or Gastrointestinal Tract Cancer (PHANTOM Trial)
Led by Lantheus Medical Imaging · Updated on 2025-08-12
26
Participants Needed
5
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the imaging agent 64Cu-LNTH-1363S in patients with sarcomas or gastrointestinal tract (GIT) cancers to assess its safety, determine the best imaging dose and timing, and compare the imaging results with fibroblast activation protein (FAP) expression in tumor samples. This Phase 1/2a open-label study is divided into two parts and aims to better understand how this radiolabeled agent behaves in the body and how well it highlights tumors that express FAP. In Part 1, six patients with metastatic sarcomas will receive a fixed dose of 64Cu-LNTH-1363S to evaluate its distribution, radiation dose, and optimal imaging window during a one-day intervention, followed by a safety follow-up. In Part 2, approximately 20 patients with non-metastatic, operable sarcomas or GIT cancers scheduled for surgery will receive the optimal dose determined in Part 1 to study the correlation between imaging results and tissue FAP expression. Both parts include detailed cardiac monitoring to assess any changes in heart activity related to the agent. Participants will undergo screening before receiving the imaging agent, followed by serial PET/CT scans at multiple timepoints on the intervention day to measure biodistribution and image quality. Tissue samples collected during surgery will be analyzed to compare with imaging findings. Safety and tolerability will be monitored through follow-up visits, ECGs, and phone contact. The total study duration varies from about three weeks for Part 1 to up to 11 weeks for Part 2, including surgery and post-surgery sample collection.
CONDITIONS
Brief Title
64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 15 years or older who have provided informed consent and assent where applicable; those aged 15 to under 18 years must weigh at least 55 kg
- Histological, pathological, or cytological confirmation of metastatic sarcoma (Part 1) or sarcoma or gastrointestinal tract cancers planned for surgery within 60 days (Part 2)
- Suspected fibroblast activation protein (FAP) expressing tumors
- Willingness to provide adequate tumor tissue samples for analysis
- Adequate kidney function with creatinine clearance of 60 mL/min or higher
- Women of childbearing potential must have a negative pregnancy test, not be breastfeeding, and agree to use highly effective contraception during the study and for 28 days after last dose
- Male participants able to father a child must agree to use effective contraception and avoid sperm donation during the study and for 28 days after last dose
You will not qualify if you...
- Unlikely to comply with study procedures or restrictions
- Known pregnancy or breastfeeding
- PET scan done within 10 physical half-lives of the PET agent prior to study intervention
- Participation in another clinical trial at time of screening
- Systemic anti-cancer therapy administered within 14 days before intervention (Part 1) or neoadjuvant therapy within 14 days before intervention (Part 2)
- PET or SPECT imaging with any other FAP inhibitor imaging agent within 6 months before or after this trial
- History of QT/QTc interval prolongation or taking medications known to prolong QT/QTc
- Additional risk factors for certain heart rhythm problems such as heart failure, low potassium, or family history of long QT syndrome
- Evidence of metastatic or advanced inoperable disease (Part 2) if applicable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 14 days
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single dose of 64Cu-LNTH-1363S for PET/CT imaging to determine biodistribution, dosimetry, optimal dose, and imaging time window.
Multiple imaging visits on Day 1 at approximately 0.5, 1, 2, 4 to 6, and 24 hours post dose
Duration - 7 days after intervention
Participants are monitored for safety and tolerability after receiving the study intervention.
1 follow-up visit or telephone contact
Duration - Up to 60 days post intervention
Participants planned for surgery undergo surgery and tumor tissue collection for immunohistochemistry analysis to correlate with imaging results.
1 surgery visit plus tumor sample collection
Trial Site Locations
Total: 5 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
UC Irvine Health - Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
3
Stanford Hospital & Clinics
Stanford, California, United States, 94305
Actively Recruiting
4
BAMF Health, Inc.
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
5
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Actively Recruiting
Research Team
E
Eryn Bagley
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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