A microchip implanted in tumors could reveal which drugs work best
NCT ID NCT04045470
First seen Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time
Summary
This pilot study tests a small microdevice that is temporarily placed inside a skin lesion to release up to 19 different cancer drugs at once. The goal is to see if the device can safely and effectively show which drugs kill the cancer cells in that specific patient. The study involves people with cutaneous T-cell lymphoma or peripheral T-cell lymphoma that has spread to the skin. The main focus is on safety and whether the device can be retrieved with enough usable tissue for analysis.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a microdevice that releases up to 19 drugs directly into a cancerous skin lesion to test which drugs are most effective
- What this could lead to
- If successful, this microdevice could help doctors quickly identify the most effective drugs for each patient's lymphoma, personalizing treatment and avoiding ineffective therapies.
- What could go wrong
- This is a very early pilot study with only 20 participants, focused on safety and feasibility. The device may cause side effects or fail to provide useful results.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2019
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants must have clinical diagnosis of cutaneous T-cell lymphoma or peripheral T-cell lymphoma with cutaneous involvement supported by histological evaluation of skin lesions. * Participants must have measurable cutaneous disease, based on the modified Severity Weighted Assessment Tool (mSWAT; definition provided in appendix E). Skin lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. * Two lesions are amenable to placement of multiple devices in terms of lesion size and location, as assessed by dermatologist (minimum diameter of 1.5 cm). * Patient must have the following minimum washout period from previous treatments and cannot be on any systemic therapy at the time of implantation. * 2 week from topical therapies of lesional skin selected for implantation * 2 weeks from retinoids, interferons, vorinostat, romidepsin, therapeutic doses of oral corticosteroids (physiologic replacement doses of oral corticosteoids are allowed) * 4 weeks from phototherapy * 5 half-lives for systemic cytotoxic anticancer agents, monoclonal antibodies, and investigational therapy * 12 weeks from local radiation therapy of lesional skin selected for implantation * 15 weeks from systemic immunotherapy targeting PD-1/PD-L1 * Age minimum of age 18. * ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A). * Participants will undergo laboratory testing within 28 days prior to the procedure. Participants must have marrow function as defined below: * absolute neutrophil count ≥500/mcL * platelets ≥50,000/mcL * Participants must be evaluated by a dermatologist or medical oncologist who will determine the clinically appropriate treatment strategy based on clinical history and extent of disease. Systemic therapy will be mandatory for cohort 2/expansion cohort, not for cohort 1. Systemic therapy may be initiated anytime within 4 weeks of MD removal. * Patients must be deemed medically stable to undergo percutaneous procedures by their treating cutaneous oncologist. * Ability to understand and the willingness to sign a written informed consent document. * Patients must be willing to undergo research-related genetic and transcriptomic sequencing (somatic and germline) and data management, including the deposition of de-identified genetic sequencing data in NIH central data repositories. * Patient is considered to have capacity to properly follow instructions at home for the care of device(s) that will each have an attached thin guidewire protruding through the skin and fixed in place (see Appendix B). Exclusion Criteria: * Positive serum pregnancy test at screening visit. * Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or biopsy procedures * History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in this study. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Patients who will receive standard of care systemic therapy are not allowed to start any new skin directed therapy (e.g. topical steroids, radiation, phototherapy) concurrent with first systemic therapy initiated after device implantation and retrieval. Should a patient clinically progress on first systemic therapy and require a change in treatment, skin directed therapies may be introduced. * Patients unable to undergo treatment wash-out period due to rapidly progressive disease requiring immediate systemic therapy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dana Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02115, United States
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