RecruitingPhase 1ACTRN12624000085572

Gallium Imaging Pilot Study in Metastatic Melanoma

A Multicentre, Phase 1 Study Investigating the Safety, Tumor Uptake, Biodistribution, and Dosimetry of 68Ga-A9T-3202 in Participants with Locally Advanced or Metastatic Melanoma


Sponsor

Alpha-9 Theranostics Australia Pty Ltd

Enrollment

30 participants

Start Date

Apr 24, 2024

Study Type

Interventional

Conditions

Summary

This study aims to assess the safety and tolerability of a new tumour imaging agent in patients with locally advanced or metastatic melanoma. Who is it for? You may be eligible for this study if you are an adult aged 18 years or older and have been diagnosed with locally advanced or metastatic melanoma. All potential participants will be reviewed by the study investigators to ensure that they meet additional health criteria before enrolment. Study details All participants who choose to consent in this study will undergo a screening visit to assess their eligibility. An 18F-FDG-PET and CT scans will be required for assessing participant eligibility, however if these scans were performed as part of standard of care prior to the date of consent but are within 28 days of the Day 1, they may not need to be repeated. Each participant's circumstances will be assessed by a study investigator and participants will be advised if scans need to be repeated. If eligible, participants will receive a single dose of 68Ga-A9T-3202 via intravenous injection, and then undergo 4 whole body PET-CT scans at set timepoints on the day of administration. Participants will then complete an End of Observation visit (one day post IP administration) to check participant safety and tolerability of 68Ga-A9T-3202. It is hoped this research will demonstrate that 68Ga-A9T-3202 is safe and well tolerated by patients with metastatic melanoma, and provide more accurate staging and treatment response evaluation when compared to the current standard of care PET/CT imaging.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This pilot study is testing a new imaging agent called 68Ga-A9T-3202 in patients with locally advanced or metastatic melanoma — a type of skin cancer that has spread beyond its original site. The agent is injected intravenously and taken up by tumour cells, where it can be detected using a PET-CT scanner. The goal is to find out whether this new agent is safe and well tolerated, and whether it can identify cancer deposits more accurately than the current standard imaging method (18F-FDG-PET). Participants will receive a single injection of the imaging agent and then undergo four whole-body PET-CT scans at different time points on the same day, to track how the agent moves through and accumulates in the body. A safety check-up will be done the following day. This study is not a treatment trial — it is purely about improving how melanoma is detected and staged, which can directly influence treatment decisions. You may be eligible if you are 18 or older, have confirmed locally advanced or metastatic melanoma visible on recent imaging, and are in reasonably good health (ECOG performance status 0 or 1). You are not eligible if you have severe claustrophobia, significant heart disease, uncontrolled infections, a history of organ transplant, or are pregnant or breastfeeding.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This study involves the use of an investigational imaging product, 68Ga-A9T-3202. 68Ga-A9T-3202 is an investigational imaging agent being developed for patients with MC1R positive metastatic melan

This study involves the use of an investigational imaging product, 68Ga-A9T-3202. 68Ga-A9T-3202 is an investigational imaging agent being developed for patients with MC1R positive metastatic melanoma. A single dose of 68Ga-A9T-3202 will be administered via intravenous injection by a Nuclear Medicine Physician prior to whole body PET-CT scans being performed at 4 timepoints post dose (15mins, 30mins, 60mins and 150mins post dose for conventional scanners; dynamic scan at 0-30mins post dose, static scans at 60mins, and 120min with an optional scan at 240mins post dose for Long Axial Field-of-View scanners). The radioactivity of the injected dose will be determined according to body weight, with a target administration activity of 2MBq/kg ±10%. The maximum administered activity will not exceed 300MBq.


Locations(1)

VIC, Australia

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