Targeted Imaging of Melanoma for Alpha-Particle Radiotherapy (TIMAR1 Trial)

Phase 1

Waitlist Available

Led By Frances L Johnson, MD

Research Sponsored by Perspective Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visit 1 (day 1) through visit 5 (approximately day 60 but could extend up to day 108); ongoing serious adverse events (sae) will be followed for no longer than day 65 or 30 days from the date of the sae report (whichever is later).

Awards & highlights

No Placebo-Only Group

Summary

This trial tests two new imaging agents to see if they can safely help doctors see melanoma tumors in patients with advanced cancer. These agents attach to specific parts of the tumor and light them up on special scans. The study aims to improve how doctors find and treat melanoma.

Eligible Conditions

Skin Cancer
Melanoma
Uveal Melanoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 1 (day 1) through visit 5 (approximately day 60 but could extend up to day 108); ongoing serious adverse events (sae) will be followed for no longer than day 65 or 30 days from the date of the sae report (whichever is later).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visit 1 (day 1) through visit 5 (approximately day 60 but could extend up to day 108); ongoing serious adverse events (sae) will be followed for no longer than day 65 or 30 days from the date of the sae report (whichever is later).

This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 1 (day 1) through visit 5 (approximately day 60 but could extend up to day 108); ongoing serious adverse events (sae) will be followed for no longer than day 65 or 30 days from the date of the sae report (whichever is later). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Area Under the Plasma Concentration Versus Time Curve (AUC) for [203Pb]VMT01

Biodistribution of [203Pb]VMT01

Biodistribution of [68Ga]VMT02

+4 more

Secondary study objectives

Cancer Site Correlation Between Standard of Care Imaging Compared to Study Imaging

Dosimetry will be Calculated for each Study Imaging Agent by Measuring the Cumulative Absorbed Dose of Radiation to the Participant's Individual Organs and Tumors

MC1R Expression Correlation Between Archived Tumor Tissue and Study Imaging

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: [203Pb]VMT01 firstActive Control2 Interventions

Participants randomized to this arm will receive imaging agent \[203Pb\]VMT01 and undergo SPECT/CT imaging first. Later, participants in this arm will receive \[68Ga\]VMT02 and undergo PET/CT imaging.

Group II: [68Ga]VMT02 firstActive Control2 Interventions

Participants randomized to this arm will receive imaging agent \[68Ga\]VMT02 and undergo PET/CT imaging first. Later, participants in this arm will receive \[203Pb\]VMT01 and undergo SPECT/CT imaging.

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