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Radiotherapy

[203Pb]VMT01 first for Skin Cancer (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

TIMAR1 Trial Summary

This trial is testing if two new imaging agents are safe for use in humans and if they can be used to image melanoma tumors.

Eligible Conditions

Skin Cancer
Melanoma
Uveal Melanoma

TIMAR1 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Biodistribution of [203Pb]VMT01

Biodistribution of [68Ga]VMT02

+4 more

Secondary outcome measures

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

TIMAR1 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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Who is running the clinical trial?

Perspective TherapeuticsLead Sponsor

4 Previous Clinical Trials

148 Total Patients Enrolled

Viewpoint Molecular TargetingLead Sponsor

3 Previous Clinical Trials

124 Total Patients Enrolled

Mayo ClinicOTHER

3,205 Previous Clinical Trials

3,766,777 Total Patients Enrolled

Media Library

[203Pb]VMT01 (Radiotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04904120 — Phase 1

Skin Cancer Research Study Groups: [203Pb]VMT01 first, [68Ga]VMT02 first

Skin Cancer Clinical Trial 2023: [203Pb]VMT01 Highlights & Side Effects. Trial Name: NCT04904120 — Phase 1

[203Pb]VMT01 (Radiotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04904120 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which patient populations are eligible to partake in this research study?

"This melanoma study is looking for 10 volunteers aged 18-89 that have the capacity to remain still and flat during a two hour imaging session, as well as having a minimum predicted life expectancy of 3 months."

Answered by AI

How many people are participating in this research program?

"Affirmative, clinicaltrials.gov confirms that this medical experiment is currently enrolling individuals. The trial was first posted on March 5th 2021 and has been recently updated on August 5th 2022 with the aim of 10 participants at a single centre."

Answered by AI

Will geriatric individuals be accepted into this investigation?

"To be eligible for this trial, applicants must lie between the ages of 18 to 89. Alternatively, there are 52 trials catered towards those under 18 and 749 clinical studies available to individuals 65 years or older."

Answered by AI

Could you discuss what risks [68Ga]VMT02 poses to patients?

"Due to the initial stage of testing, [68Ga]VMT02 has been tentatively assessed with a score of 1 on our safety scale. This reflects that there is limited evidence regarding both its efficacy and potential risks."

Answered by AI

Does this medical experiment still have capacity for new participants?

"Indeed, the clinical trial is open for recruitment indicated by data posted on clinicaltrials.gov. This research was initially published on March 5th 2021 and was recently revised on August 5th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Targeted Imaging of Melanoma for Alpha-Particle Radiotherapy

2021. "Targeted Imaging of Melanoma for Alpha-Particle Radiotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04904120.