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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 below

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I am 18 or older and have given my written consent.

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My sarcoma is suspected to express FAP and has spread.

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My cancer is a confirmed type of metastatic sarcoma.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and post surgery tissue collection to end of study for reporting.

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 more

Other 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).

0 / 4Eligibility criteria met