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NCT05457842 · ClinicalTrials.gov registry record · Phase 2
A Study to Find the Best Dose of ASP5354 to Show Lymph Nodes in People With Breast Cancer or Melanoma During Surgery
A Phase 2 study, sponsored by Astellas Pharma.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT05457842 is a Phase 2 study that was terminated before completion, run by Astellas Pharma. The registered enrollment target is 1 participants.
The verdict
NCT05457842, a Phase 2 study, was terminated before completion, sponsored by Astellas Pharma.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
This study was for women with breast cancer and for adults with melanoma. Breast cancer was a type of cancer when cells in the breast turn into cancer cells, which might grow out of control. Melanoma was a type of skin cancer that starts in cells called melanocytes. These cells made a substance called melanin which gives the skin its color. In this study, people had surgery to remove the lymph node closest to the site of their cancer. This lymph node was called the sentinel node. This was done to check if the cancer had spread from the original site to the sentinel node. This procedure was called a sentinel node biopsy. This study provided more information on a potential new dye, called ASP5354, used in sentinel node biopsies. ASP5354 helped to show the lymph nodes more clearly during surgery. This helped the surgeon find the lymph node closest to the site of the cancer (sentinel node). The main aim of the study was to find the best dose of ASP5354 that clearly showed the lymph nodes during surgery. This was an open-label study. That means each person in the study and the study doctors knew that person received ASP5354. Each person only received 1 dose of ASP5354. People that wanted to take part in the study were checked by a study doctor. This was on a separate visit before their surgery. Before surgery, people who took part in the study were asked if they had any other medical problems. They had a physical exam, an ECG to check their heart rhythm, and had their vital signs checked (blood pressure, pulse rate, and breathing rate). Other checks included some blood and urine samples taken for laboratory tests. During surgery, a study surgeon injected ASP5354 near the cancer site. They recorded how clearly they could see the lymph nodes. Some blood samples were taken for laboratory tests and an ECG was done. After their surgery, people were asked if they have any other medical problems. People returned to the hospital 9 days later for a check-up. The check-up in
Interventions
- DRUG pudexacianinium chloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2022-08-10 |
| Est. Completion | 2022-09-20 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05457842
The ClinicalTrials.gov registry entry for NCT05457842 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma, which has 165 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which pudexacianinium chloride is the first listed.
NCT05457842 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05457842 about?
NCT05457842 is a clinical study titled "A Study to Find the Best Dose of ASP5354 to Show Lymph Nodes in People With Breast Cancer or Melanoma During Surgery". This study was for women with breast cancer and for adults with melanoma. Breast cancer was a type of cancer when cells in the breast turn into cancer cells, which might grow out of control. Melanoma was a type of skin cancer that starts in cells called melanocytes. These cells made a substance call...
What is the current status of trial NCT05457842?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2022-08-10. Estimated completion is 2022-09-20.
What interventions are being tested in trial NCT05457842?
The interventions under investigation include: pudexacianinium chloride (DRUG).
Who is sponsoring clinical trial NCT05457842?
This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.
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