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Intratumoral Targeted Hyperthermia Therapy (THT) for Cutaneous Metastatic Melanoma

NCT06870994 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-04-24

No results posted yet for this study

Summary

This device phase I/II, first in human, early feasibility study (EFS), open-label, single-arm trial aims to evaluate the safety, tolerability, and preliminary efficacy of Gold Nanorod (GNR)-enabled sub-ablative targeted hyperthermia therapy (THT) in patients with unresectable stage 3C/3D/4M1 cutaneous metastatic malignant melanoma that have failed to respond to systemic checkpoint and localized intra-tumoral immunotherapy. The study will involve up to 10 participants with stable or progressive cutaneous and/or subcutaneous skin lesions (Immune Stable Disease (iSD) or Immune Confirmed/Unconfirmed Progressive Disease (iCPD/iUPD)).

GNRs, when administered via intra-tumoral injection and activated by NIR light, generate localized heat through a process called THT. This approach selectively targets tumor cells while minimizing damage to surrounding healthy tissue. In this study, 10 participants will receive two THT treatments spaced 7 days apart.

The primary objective of this study is to assess the safety and tolerability of THT treatment.

Conditions

  • Cutaneous Metastatic Melanoma

Interventions

DEVICE

Targeted Hyperthermia Therapy

Intra-tumoral gold nanorods (SivaRods) exposed to Near Infrared Light (860 +/- 10nm) mediated targeted hyperthermia therapy

Sponsors & Collaborators

  • Nova Scotia Health Authority

    collaborator OTHER

  • Sona Nanotech Inc

    lead INDUSTRY

Principal Investigators

  • Lucy K Helyer, MD · Nova Scotia Health

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2026-12-30
Completion
2026-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06870994 on ClinicalTrials.gov