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Cancer Imaging Agent
64Cu-LNTH-1363S for Sarcoma and Gastrointestinal Cancer (PHANTOM Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Lantheus Medical Imaging
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must be ≥ 18 years of age and must have provided written informed consent.
Patients with suspected FAP-expressing metastatic sarcoma.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of part 2 to 6 patients enrolled with qualifying imaging
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test the safety and effectiveness of a new imaging agent called 64Cu-LNTH-1363S in patients with sarcomas or gastrointestinal cancers. The study will be done
Who is the study for?
This trial is for adults with certain types of sarcoma or gastrointestinal cancers, like esophageal, colorectal, stomach, and pancreatic cancer. Participants must have metastatic sarcoma confirmed by medical tests and adequate kidney function. Women who can bear children and men able to father a child must use effective contraception.
What is being tested?
The study is testing the safety and optimal imaging dose of a new PET/CT scan agent called 64Cu-LNTH-1363S in two parts. It aims to see how well this agent shows up on scans compared to the actual presence of FAP (a protein) in tumors.
What are the potential side effects?
Since this trial focuses on an imaging agent used during PET/CT scans rather than a drug treatment, typical side effects may include reactions at the injection site or allergic reactions but will be detailed as the trial progresses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older and have given my written consent.
Select...
My sarcoma is suspected to express FAP and has spread.
Select...
My cancer is a confirmed type of metastatic sarcoma.
Select...
My kidneys work well, with a creatinine clearance rate of 60 mL/min or higher.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post surgery tissue collection to end of study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post surgery tissue collection to end of study
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Primary Part 1 - Optimal dose (radioactivity and mass dose) and imaging time window of 64Cu-LNTH-1363S
Primary Part 1 Biodistribution of 64Cu-LNTH-1363S
Primary Part 2 - Correlation of 64Cu-LNTH-1363S biodistribution with Immunohistochemistry FAP expression
Secondary study objectives
Secondary Part 1 FAP expression profile of 64Cu-LNTH-1363S in patients with sarcoma
Secondary Part 1 and Part 2 Cardiac Safety
Secondary Part 2 Validate optimal radioactivity in patients with sarcoma or GIT cancer
+1 moreOther study objectives
Exploratory Part 1 and Part 2
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Experimental Part 2Experimental Treatment1 Intervention
Part 2 will evaluate 64Cu-LNTH-1363S (64Cu Radiolabeled FAPi PET/CT Imaging Agent) correlation with FAP expression measured by IHC (SUVmax and SUVmean vs IHC score) in 20 evaluable patients with non-metastatic, operable, supposed FAP-expressing solid tumors (sarcomas, esophageal, gastric, pancreatic, colorectal) planned for surgery within 60 days (from study imaging).
Group II: Experimental Part 1Experimental Treatment1 Intervention
Six patients with metastatic sarcoma will receive 8 ± 1 millicurie (mCi) (\~50 μg mass dose) of 64Cu-LNTH-1363S (64Cu Radiolabeled FAPi PET/CT Imaging Agent).
Six patients with metastatic sarcoma will receive 8 ± 1 millicurie (mCi) (\~90 μg mass dose) of 64Cu-LNTH-1363S (64Cu Radiolabeled FAPi PET/CT Imaging Agent).
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Who is running the clinical trial?
Lantheus Medical ImagingLead Sponsor
56 Previous Clinical Trials
4,332,644 Total Patients Enrolled