New Light-Measuring tool tested in cancer surgery
NCT ID NCT03678350
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested a light-measuring system used during photodynamic therapy (PDT) for people with malignant mesothelioma, non-small cell lung cancer, or other pleural cancers. Nine participants received the drug porfimer sodium, which becomes active when exposed to light, during surgery. The goal was to see if measuring the light dose could help doctors decide when to stop or continue treatment, and to check for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- porfimer sodium (Photofrin)
- What this could lead to
- If successful, this could help doctors deliver the right amount of light during photodynamic therapy, potentially improving treatment for pleural cancers.
- What could go wrong
- This is a very early, small Phase I trial with only 9 participants, focused on safety and light measurement, not on curing the disease. The approach may not work for everyone and carries risks from the light-activated drug.
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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
9 people
The number who actually took part.
- Started
-
Sep 2021
- Finished
-
Oct 2025
- Lead sponsor
-
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
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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: * Histologically confirmed malignant mesothelioma , non-small cell lung cancer (NSCLC) or other malignancies with pleural disease without distant disease. * Subjects must have an Eastern Cooperative Oncology Group (ECOG) scale of 0-2. * Subjects of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for 6 months after surgery. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. * The subject must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent prior to receiving any study related procedure. Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. * Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. * White blood cell (WBC) \< 4,000. * Platelet count \< 100,000. * Total serum bilirubin \> 2 mg/dL. * Serum creatinine \> 2 mg/dL. * Alkaline phosphatase \> 3 times the upper normal limit. * Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) \> 3 times the upper normal limit. * 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. * Pregnant or nursing female subjects. * Unwilling or unable to follow protocol requirements. * Any condition which in the investigator?s opinion deems the subject an unsuitable candidate to receive porfimer sodium. * Received an investigational agent within 30 days prior to enrollment.
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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.
Contacts and locations
Locations
-
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
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