NCT04377360

Brief Summary

This is a single-institution pilot feasibility trial in which 10 subjects will be enrolled. The primary objectives are is to explore the feasibility of delivering radiotherapy for malignant skin and superficial soft tissue tumors using DaRT (Alpha Tau Medical, Tel Aviv, Israel), a form of interstitial brachytherapy which uses a novel radioisotope delivery system, as well as to determine the frequency and severity of acute adverse events. Secondary objectives will include assessments of radiotherapy-related adverse events, tumor response, radiation safety, stability of device placement, and associations with quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

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 Start

First participant enrolled

January 6, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2022

Completed
Last Updated

June 1, 2022

Status Verified

July 1, 2021

Enrollment Period

2.2 years

First QC Date

April 29, 2020

Last Update Submit

May 30, 2022

Conditions

Malignant Skin TumorSoft Tissue Tumor, Malignant

Keywords

Skin TumorSuperficial Soft Tissue Tumor

Outcome Measures

Primary Outcomes (2)

  • Feasibility of DaRT Delivery

    To explore feasibility of delivering radiotherapy for malignant skin and superficial soft tissue tumors using Diffusing Alpha-emitter Radiation Therapy (DaRT). Feasibility will be determined by successful delivery of radiation by DaRT to the malignant tumor. If an attempt to place the DaRT is unsuccessful, this patient will be considered a feasibility failure. A feasibility failure may be due to inability to execute the workflow of pre-brachytherapy imaging, treatment planning, device procurement, or technical inability to place the DaRT sources into the skin and superficial soft tissue tumor. The rate of feasibility failures will be reported.

    1 Day

  • Frequency and Severity of Adverse Events

    To determine the frequency and severity of acute adverse events related to DaRT for skin and superficial soft tissue tumors. Adverse events will be assessed and graded according to Common Terminology and Criteria for adverse events (CTCAE) version 5.0.

    Up to 24 Weeks after DaRT Removal

Secondary Outcomes (5)

  • Rate of Tumor Response using Response Evaluation Criteria in Solid Tumors (RECIST)

    3 Months

  • Radiation Exposure Safety using a Calibrated Survey Probe

    1 Day

  • Stability Assessment of the DaRT Sources after Placement

    2 Weeks

  • Quality of Life Assessment using the Skindex-16

    2 Weeks after DaRT Placement and 6, 12, 24 Weeks after DaRT Removal

  • Quality of Life Assessment using the Skin Cancer Index (SCI)

    2 Weeks after DaRT Placement and 6, 12, 24 Weeks after DaRT Removal

Study Arms (1)

Diffusing Alpha-emitter Radiation Therapy (DaRT)

EXPERIMENTAL

DaRT source will be inserted using preplanned radiotherapy parameters and reassessed by volumetric imaging 2-3 weeks after placement and then removed. Tumor response to DaRT will be assessed periodically 3 months after removal.

Radiation: Diffusing Alpha-emitter Radiation Therapy

Interventions

Diffusing Alpha-emitter Radiation TherapyRADIATION

Diffusing Alpha-emitter Radiation Therapy (DaRT) is a method of delivering interstitial brachytherapy, based on the interstitial intratumoral placement of an encapsulated Radium-224 source (3.7 days half-life). These sources release short-lived alpha-emitting atoms into the tumor microenvironment by recoil. As the radioisotope has a short half-life, the majority of radiation absorption happens in the tumor.

Also known as: DaRT
Diffusing Alpha-emitter Radiation Therapy (DaRT)

Eligibility Criteria

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

You may not qualify if:

  • Contraindication to radiotherapy for skin and superficial soft tissue tumor
  • Radiotherapy to the malignant skin or soft tissue tumor planned for radiotherapy within last 6 months
  • Prior radiotherapy to the malignant skin or soft tissue tumor planned for radiotherapy with doses \> 60 Gy (equivalent dose in 2 Gy fractions using α/β of 8.5)
  • Anticoagulation or antiplatelet medical therapy
  • High probability of non-compliance with scheduled assessments as demonstrated by prior inability to complete scheduled routine clinical assessments
  • Pregnancy
  • Women of childbearing potential unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 1 year after brachytherapy
  • Men unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 1 year after brachytherapy
  • Inability to read or understand English (as QoL questionnaires are only validated in English)
  • Concurrent receipt of cancer therapy which has proven effective for the malignant skin or soft tissue tumor planned for radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

UnityPoint Health - John Stoddard Cancer Center

Des Moines, Iowa, 50309, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

West Cancer Center & Research Institute

Germantown, Tennessee, 38138, United States

Location

University Cancer & Diagnostic Center

Houston, Texas, 77089, United States

Location

Dermatology of Seattle and Bellevue

Seattle, Washington, 98168, United States

Location

Related Publications (1)

  • D'Andrea MA, VanderWalde NA, Ballo MT, Patra P, Cohen GN, Damato AL, Barker CA. Feasibility and Safety of Diffusing Alpha-Emitter Radiation Therapy for Recurrent or Unresectable Skin Cancers. JAMA Netw Open. 2023 May 1;6(5):e2312824. doi: 10.1001/jamanetworkopen.2023.12824.

    PMID: 37166798DERIVED

MeSH Terms

Conditions

Skin NeoplasmsSarcoma

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms, Connective and Soft TissueNeoplasms by Histologic Type

Study Officials

  • Christopher Barker, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a multi-center feasibility trial with DaRT for the treatment of malignant skin and superficial soft tissue tumors.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2020

First Posted

May 6, 2020

Study Start

January 6, 2020

Primary Completion

March 28, 2022

Study Completion

March 28, 2022

Last Updated

June 1, 2022

Record last verified: 2021-07

Locations

US(5)