Malignant Skin TumorNCT04377360
Feasibility Trial of Diffusing Alpha-emitter Radiation Therapy (DaRT) for Malignant Skin & Superficial Soft Tissue Tumors
A study testing Diffusing Alpha-emitter Radiation Therapy in people with Malignant Skin Tumor and Soft Tissue Tumor, Malignant, run by Alpha Tau Medical LTD. at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Skin Tumor, Soft Tissue Tumor, Malignant
- What is being tested?
- Diffusing Alpha-emitter Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 5 sitesUnited States
- Study dates
- 6 Jan 2020to 28 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Malignant tumor of the skin or superficial soft tissue*, ≥10 mm and ≤50 mm in longest dimension, with minimum tumor thickness of 4 mm
- *Including, but after review by the Principal Investigator not limited to:
- Primary malignant tumors of the skin such as keratinocytic carcinomas (basal cell carcinoma, squamous cell carcinoma), melanocytic tumors (melanoma), soft tissue tumors (cutaneous angiosarcoma or leiomyosarcoma), and neural tumors (Merkel cell carcinoma)
- Primary malignant tumors of the superficial soft tissues such as adipocytic tumors (liposarcoma), smooth-muscle tumors (leiomyosarcoma), skeletal muscle tumors (rhabdomyosarcoma), vascular tumors (Kaposi sarcoma, angiosarcoma of soft tissue)
- Secondary malignant tumors of the skin and superficial soft tissues such as metastases from breast cancer, lung cancer, melanoma, kidney cancer and others.
- Limited treatment options for the tumor, including:
- Recurrent tumors that must have failed at least one standard therapy, which includes previous radiotherapy or surgery, OR
- Tumors in patients with metastases who will not be rendered disease-free by tumor resection, OR
- Tumors deemed inappropriate for resection by a surgeon for one of the following reasons:
- Complete tumor resection unlikely because of tumor location or size;
- Complete tumor resection deemed excessively morbid or deforming (e.g., requiring amputation of digit, lip, eyelid, ear);
- Patient with medical comorbidity contraindicating surgery; or
- Patent refusal due to anticipated morbidity
- Age >18 years
- Eastern cooperative oncology group performance status ≤3
- Life expectancy ≥12 weeks
- Platelet count ≥50,000/mm3
- International normalized ratio of prothrombin time ≤1.8
- Creatinine ≤1.9 mg/dL
Subject Exclusion Criteria
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
UnityPoint Health - John Stoddard Cancer Center
Des Moines, Iowa, 50309
West Cancer Center & Research Institute
Germantown, Tennessee, 38138
University Cancer & Diagnostic Center
Houston, Texas, 77089
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Dermatology of Seattle and Bellevue
Seattle, Washington, 98168
About this study
Official title: A Pilot Feasibility Trial of Diffusing Alpha-emitter Radiation Therapy (DaRT) for Malignant Skin and Superficial Soft Tissue Tumors
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.
Read the detailed description
Diffusing Alpha-emitter Radiation Therapy is a form of interstitial brachytherapy which may be effective in treating malignant skin and superficial soft tissue tumors for several reasons. First, alpha-emitting radionuclides have a high linear energy transfer (LET), which produces a dense track of ionization events within cells and DNA, which produce complex DNA damage and more effective cell kill than more sparsely ionizing forms of radiation, such as gamma-rays or x-rays. Second, alpha-emitting radionuclides exhibit a higher relative biologic effect (RBE) compared to gamma-rays or x-rays, due to the relative insensitivity to cancer cellular radiosensitivity associated with cell cycling. Finally, alpha-emitting radionuclides are relatively insensitive to hypoxia, which is common as malignant skin and superficial soft tissue tumors become larger (Hall 2000).
Alpha particles have been considered unsuitable for treatment of solid tumors, since no practical method to effectively irradiate a macroscopic tumor with these short-range particles (penetration range in human tissue of ≤0.1 mm) has been found.
The "Diffusing Alpha-emitter Radiation Therapy (DaRT)", based on the interstitial intratumoral placement of an encapsulated Radium-224 source (3.7 days half-life), is described in this study. These sources release short-lived alpha-emitting atoms into the tumor microenvironment by recoil. These atoms are dispersed in the immediate surrounding tumor microenvironment both by convection through tumor interstitial fluid and by thermal diffusion. The decay of Radium-224 in the capsule results in the release of the short-lived (half-life of about 1 minute) radioisotope Radon-220. Radon-220 migrates in the tumor microenvironment until it decays. This is followed by the decay of its daughter radioisotope, Polonium-216. Lead-212, the result of this last decay, gives rise to Bismuth-212, which emits yet another alpha particle. The result of these decay events is the release of alpha particles (Kelson 1994 and Kelson 1995). DaRT will be used in this study for the treatment of malignant skin and superficial soft tissue tumors.
This study has been designed to determine the feasibility of performing the procedure required to deliver radiotherapy to the tumor. At the same time, the safety of the treatment, tumor response, radiation safety, device placement stability, and patient reported quality of life, and molecular and histologic effects on the tumor will be assessed.
The DaRT sources will be inserted using preplanned radiotherapy parameters, with a specified number and size of DaRT sources. Approximately 2-3 weeks after placement of the DaRT sources, the placement of the sources will be reassessed by volumetric imaging, and then they will be removed. Tumor response to DaRT will be assessed periodically 3 months after removal of the device.
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.
- Conditions
- Malignant Skin Tumor, Soft Tissue Tumor, Malignant
- Being tested
- Diffusing Alpha-emitter Radiation Therapy
- Keywords
- Skin Tumor, Superficial Soft Tissue Tumor
- Medical subject headings
- Skin Neoplasms, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusing Alpha-emitter Radiation TherapyRadiation
Also called DaRT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Diffusing Alpha-emitter Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 24 Weeks after DaRT Removal
Secondary outcomes (5)
Rate of Tumor Response using Response Evaluation Criteria in Solid Tumors (RECIST)
To assess the rate of malignant skin and superficial soft tissue tumor response after DaRT. Tumor response will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 using calibrated digital photography and CT imaging 3 months after DaRT.
Measured: 3 Months
Radiation Exposure Safety using a Calibrated Survey Probe
To assess radiation safety through determination of patient and personnel radiation exposure during DaRT. Radiation exposure will be measured using a calibrated survey probe.
Measured: 1 Day
Stability Assessment of the DaRT Sources after Placement
To assess stability of the DaRT sources after placement. Stability will be assessed by localization of the DaRT sources in the tumor after placement, measured by geometric comparisons of the DaRT sources relative to the centroid of the tumor, using brachytherapy planning software. Distance of the DaRT sources relative to the centroid immediately at the time of initial placement and immediately before removal will be analyzed and reported numerically.
Measured: 2 Weeks
Quality of Life Assessment using the Skindex-16
To assess skin-related and cancer-related quality of life (QoL) after DaRT. QoL will be assessed using the Skindex-16 following placement of the DaRT. The Skindex-16 scores range from 0 to 100 (with higher scores representing lower satisfaction).
Measured: 2 Weeks after DaRT Placement and 6, 12, 24 Weeks after DaRT Removal
Quality of Life Assessment using the Skin Cancer Index (SCI)
To assess skin-related and cancer-related quality of life (QoL) after DaRT. QoL will be assessed using the Skin Cancer Index (SCI) following placement of the DaRT. The SCI scores range from 5-22 (with higher scores indicating higher QOL).
Measured: 2 Weeks after DaRT Placement and 6, 12, 24 Weeks after DaRT Removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start6 Jan 2020
- Primary completion28 Mar 2022
- Study completion28 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Skin TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a multi-center feasibility trial with DaRT for the treatment of malignant skin and superficial soft tissue tumors.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alpha Tau Medical LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Barker, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377360
- Sponsor's protocol ID
- CTP-SCC-MSK-00
- Status last verified
- Jul 2021
- First submitted
- 29 Apr 2020
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 37166798
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Trial of Diffusing Alpha-emitter Radiation Therapy (DaRT) for Malignant Skin and Superficial Soft Tissue Tumors
- ClinicalTrials.gov ID
- NCT04377360
- Acronym / sponsor ID
- CTP-SCC-MSK-00
- Conditions
- Malignant Skin Tumor, Soft Tissue Tumor, Malignant
- Keywords
- Skin Tumor, Superficial Soft Tissue Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Alpha Tau Medical LTD.Industry (pharma, biotech, devices)
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 6 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Diffusing Alpha-emitter Radiation Therapy is a form of interstitial brachytherapy which may be effective in treating malignant skin and superficial soft tissue tumors for several reasons. First, alpha-emitting radionuclides have a high linear energy transfer (LET), which produces a dense track of ionization events within cells and DNA, which produce complex DNA damage and more effective cell kill than more sparsely ionizing forms of radiation, such as gamma-rays or x-rays. Second, alpha-emitting radionuclides exhibit a higher relative biologic effect (RBE) compared to gamma-rays or x-rays, due to the relative insensitivity to cancer cellular radiosensitivity associated with cell cycling. Finally, alpha-emitting radionuclides are relatively insensitive to hypoxia, which is common as malignant skin and superficial soft tissue tumors become larger (Hall 2000).
Alpha particles have been considered unsuitable for treatment of solid tumors, since no practical method to effectively irradiate a macroscopic tumor with these short-range particles (penetration range in human tissue of ≤0.1 mm) has been found.
The "Diffusing Alpha-emitter Radiation Therapy (DaRT)", based on the interstitial intratumoral placement of an encapsulated Radium-224 source (3.7 days half-life), is described in this study. These sources release short-lived alpha-emitting atoms into the tumor microenvironment by recoil. These atoms are dispersed in the immediate surrounding tumor microenvironment both by convection through tumor interstitial fluid and by thermal diffusion. The decay of Radium-224 in the capsule results in the release of the short-lived (half-life of about 1 minute) radioisotope Radon-220. Radon-220 migrates in the tumor microenvironment until it decays. This is followed by the decay of its daughter radioisotope, Polonium-216. Lead-212, the result of this last decay, gives rise to Bismuth-212, which emits yet another alpha particle. The result of these decay events is the release of alpha particles (Kelson 1994 and Kelson 1995). DaRT will be used in this study for the treatment of malignant skin and superficial soft tissue tumors.
This study has been designed to determine the feasibility of performing the procedure required to deliver radiotherapy to the tumor. At the same time, the safety of the treatment, tumor response, radiation safety, device placement stability, and patient reported quality of life, and molecular and histologic effects on the tumor will be assessed.
The DaRT sources will be inserted using preplanned radiotherapy parameters, with a specified number and size of DaRT sources. Approximately 2-3 weeks after placement of the DaRT sources, the placement of the sources will be reassessed by volumetric imaging, and then they will be removed. Tumor response to DaRT will be assessed periodically 3 months after removal of the device.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a multi-center feasibility trial with DaRT for the treatment of malignant skin and superficial soft tissue tumors.
| Arm | Type | Receives |
|---|---|---|
| Diffusing Alpha-emitter Radiation Therapy (DaRT) | Experimental | Radiation: Diffusing Alpha-emitter Radiation TherapyDaRT 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diffusing Alpha-emitter Radiation TherapyAlso: DaRTDiffusing 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. | Radiation | Diffusing Alpha-emitter Radiation Therapy (DaRT) |
Primary outcome
Feasibility of DaRT Delivery
Time frame: 1 Day
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.
Frequency and Severity of Adverse Events
Time frame: Up to 24 Weeks after DaRT Removal
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.
5 secondary outcomes
Rate of Tumor Response using Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: 3 Months
Radiation Exposure Safety using a Calibrated Survey Probe
Time frame: 1 Day
Stability Assessment of the DaRT Sources after Placement
Time frame: 2 Weeks
Quality of Life Assessment using the Skindex-16
Time frame: 2 Weeks after DaRT Placement and 6, 12, 24 Weeks after DaRT Removal
Quality of Life Assessment using the Skin Cancer Index (SCI)
Time frame: 2 Weeks after DaRT Placement and 6, 12, 24 Weeks after DaRT Removal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Derived from this study: PubMed 37166798D'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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Barker, MD principal investigator
Memorial Sloan Kettering Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diffusing Alpha-emitter Radiation Therapy in people with Malignant Skin Tumor and Soft Tissue Tumor, Malignant, run by Alpha Tau Medical LTD. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of DaRT Delivery (time frame: 1 Day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04377360, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.