NCT05620290

Brief Summary

The objective of this study is to examine the safety profile and therapeutic efficacy of MRI-guided focused ultrasound microbubble therapy and radiotherapy in humans.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
27mo left

Started Jun 2022

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Jun 2022Jul 2028

First Submitted

Initial submission to the registry

May 17, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

June 15, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 17, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2025

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2028

Expected
Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

3.1 years

First QC Date

May 17, 2022

Last Update Submit

December 11, 2023

Conditions

Melanoma

Keywords

Focused ultrasoundMelanomaMicrobubbles

Outcome Measures

Primary Outcomes (1)

  • Incidence of toxicity and adverse events, scored on the National Cancer Institute Common Toxicity Criteria (NCI CTCAE 4.03)

    The patient will be assessed by a physician investigator and clinical research assistant (CRA) on the MRI-guided focused ultrasound + microbubble (MRgFUS + MB) treatment date and within follow up period of 90 days after treatment.

    90 days

Secondary Outcomes (1)

  • Radiological response

    2 years

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Malignant Melanoma patients undergoing MRI-guided ultrasound-stimulated microbubble treatment plus radiation therapy

Drug: DefinityDevice: Sonalleve Focused Ultrasound Device

Interventions

DefinityDRUG

Stimulation of Definity microbubbles using Sonalleve device within tumour vasculature

Treatment Arm
Sonalleve Focused Ultrasound DeviceDEVICE

Sonalleve Focused Ultrasound Device

Treatment Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • All biopsy-confirmed malignant melanoma of the skin and non melanoma skin cancer, including metastatic lesions.
  • Stage I-IV malignant melanoma and non melanoma skin cancer, per AJCC guidelines (8th Edition).
  • Patient referred for palliative radiotherapy/ standard radiotherapy/ neoadjuvant radiotherapy/ SBRT/ hypofractionation.
  • Patient on immunotherapy.
  • Able to understand and give informed consent. Weight \<140kg.
  • Target lesion visible by non-contrast MRI.
  • Target lesion accessible for MRg-FU procedure.
  • Able to communicate sensation during MRg-FU treatment.
  • Creatinine within normal institutional limits or creatinine clearance \>60 mL/min/1.73 m2 for patients with creatinine levels above the institutional upper limit of norma

You may not qualify if:

  • Pregnant or lactating women may not participate due to the embryotoxic effects of protocol treatment. Women/ men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
  • Unable to have contrast-enhanced MRI scan - the standard of care criteria
  • Target lesion involves the skin surface causing ulceration, bleeding or discharge
  • Severe cardiovascular, neurological, renal or hematological chronic disease
  • ECOG (Eastern Cooperative Oncology Group) Performance Status ≥ 3. Unable to tolerate required stationary position during treatment
  • Cardiac disease or unstable hemodynamics, including myocardial infarction within six months, unstable angina, congestive heart failure, ejection fraction \< 50%, cardiac shunts, cardiac arrhythmia and cardiac pacemaker.
  • Contraindication to perflutren including subjects with a family or personal history of QT prolongation or taking concomitant medications known to cause QTc prolongation like cisapride, erythromycin, tricyclic antidepressants, Class IA and III antiarrhythmic agents and some antipsychotics like haloperidol, droperidol, quetiapine, thioridazine, ziprasidone.
  • Severe hypertension (diastolic BP \> 100 mmHg)
  • History of bleeding disorder, coagulopathy
  • Severely impaired renal function with estimated glomerular filtration rate \< 30ml/min/1.73m2 and/or on dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

perflutren

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Dr. Gregory Czarnota, MD, Ph.D.

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Gregory Czarnota, MD, Ph.D.

CONTACT

(416) 480-6128Gregory.Czarnota@sunnybrook.ca

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2022

First Posted

November 17, 2022

Study Start

June 15, 2022

Primary Completion

July 11, 2025

Study Completion (Estimated)

July 11, 2028

Last Updated

December 15, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)