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NCT06306638 · ClinicalTrials.gov registry record · Phase 1
Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction
A Phase 1 study of Malignant Solid Neoplasm, sponsored by Roswell Park Cancer Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 53
- Enrollment target
- 2
- Study locations
NCT06306638 is a Phase 1 study of Malignant Solid Neoplasm that is actively recruiting participants, run by Roswell Park Cancer Institute. The registered enrollment target is 53 participants, below the 1,141-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT06306638, a Phase 1 study of Malignant Solid Neoplasm, is actively recruiting participants, sponsored by Roswell Park Cancer Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 53 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase I/II trial studies the side effects of interstitial photodynamic therapy following palliative radiotherapy and how well it works in treating patients with inoperable malignant central airway obstruction. Patients who have advanced stage cancer tumors in the lung can often have the breathing passages to the lung partially or completely blocked. These tumors could be due to lung cancer or other cancers (e.g., renal, breast, kidney, etc.) that spread to the lung. This blockage puts the patient at a higher risk for respiratory failure, post-obstructive pneumonia, and prolonged hospitalizations. Treatment for these patients may include bronchoscopic intervention (such as mechanical removal, stenting, laser cauterization, or ballooning), radiation therapy with and without chemotherapy. While palliative x-ray radiotherapy may help in shrinking the tumor, high dose curative radiotherapy that can ablate (a localized, nonsurgical destruction) the tumor also has high risk to cause significant toxicity, including bleeding, abnormal connections or passageways between organs or vessels and abnormal scar tissue that can also produce airway obstruction. Photodynamic therapy (PDT) is another possible treatment that can provide local control of the tumor. PDT consists of injecting a light sensitive drug (photosensitizer, PS) into the vein, waiting for the PS to accumulate in the tumor, and then activating it with a red laser light. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving interstitial photodynamic therapy following palliative radiotherapy may improve tumor response and survival without the serious side effects that are associated with the typical high dose curative x-ray radiotherapy alone in patients with malignant central airway obstruction.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- RADIATION Palliative Radiation Therapy
- PROCEDURE Endobronchial Ultrasound Bronchoscopy
- PROCEDURE Interstitial Photodynamic Therapy
Study Locations (2)
New York
- Roswell Park Cancer Institute - Buffalo
Pennsylvania
- Abramson Cancer Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2024-10-01 |
| Est. Completion | 2029-10-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06306638
The ClinicalTrials.gov registry entry for NCT06306638 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,141-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (95% lower). The listed sponsor is Roswell Park Cancer Institute, which has 365 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06306638 reports 2 study locations spanning 2 distinct geographic areas - top geographies include New York, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06306638 about?
NCT06306638 is a clinical study titled "Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction". This phase I/II trial studies the side effects of interstitial photodynamic therapy following palliative radiotherapy and how well it works in treating patients with inoperable malignant central airway obstruction. Patients who have advanced stage cancer tumors in the lung can often have the breathi...
What is the current status of trial NCT06306638?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2024-10-01. Estimated completion is 2029-10-01.
What conditions does trial NCT06306638 study?
This clinical trial studies the following conditions: Malignant Solid Neoplasm.
What interventions are being tested in trial NCT06306638?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Palliative Radiation Therapy (RADIATION), Endobronchial Ultrasound Bronchoscopy (PROCEDURE), Interstitial Photodynamic Therapy (PROCEDURE).
Who is sponsoring clinical trial NCT06306638?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06306638 being conducted?
This trial has 2 study locations across New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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