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NCT06915727 · ClinicalTrials.gov registry record · Phase 3
An Imaging Agent (Pafolacianine) for Identifying Lesions in Pediatric Patients With Primary or Metastatic Solid Tumors
A Phase 3 study of Malignant Pelvic Neoplasm and Childhood Malignant Solid Neoplasm, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06915727: Recruiting Phase 3 study of Malignant Pelvic Neoplasm and Childhood Malignant Solid Neoplasm, sponsored by Mayo Clinic.
NCT06915727 is a Phase 3 study of Malignant Pelvic Neoplasm and Childhood Malignant Solid Neoplasm that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 20 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06915727, a Phase 3 study of Malignant Pelvic Neoplasm and Childhood Malignant Solid Neoplasm, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase III trial studies how well pafolacianine works for identifying cancerous lesions in children and adolescent patients with primary solid tumors or solid tumors that have spread from where they first started (primary site) to other places in the body (metastatic). Pafolacianine is a fluorescent imaging agent that targets folate receptors which are overexpressed in many cancers and is used with near infrared (NIR) imaging during surgery to identify tumor cells. NIR uses a special camera that uses wavelengths in the infrared range to visualize and locate the tumor cells that are lit up by the pafolacianine. Giving pafolacianine for NIR imaging may work better than other imaging agents in identifying cancerous lesions in pediatric patients with solid tumors.
Primary Outcome
Each excised specimen will be analyzed for histologic findings to determine accuracy of Cytalux™ (pafolacianine) injection used with near infrared (NIR) fluorescent imaging for detecting lesions. Accuracy will be assessed using sensitivity and specificity.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Surgical Procedure
- PROCEDURE Near Infrared Imaging
- DRUG Pafolacianine Sodium
Study Locations (1)
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-04-15 |
| Est. Completion | 2027-05-01 |
| Phase | Phase 3 |
What NCT06915727 shows while recruiting
NCT06915727 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 6 conditions, with Malignant Pelvic Neoplasm appearing as the primary indexed condition, and to 4 interventions - of which Biospecimen Collection is the first listed.
NCT06915727 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT06915727 about?
NCT06915727 is a clinical study titled "An Imaging Agent (Pafolacianine) for Identifying Lesions in Pediatric Patients With Primary or Metastatic Solid Tumors". This phase III trial studies how well pafolacianine works for identifying cancerous lesions in children and adolescent patients with primary solid tumors or solid tumors that have spread from where they first started (primary site) to other places in the body (metastatic). Pafolacianine is a fluores...
What is the current status of trial NCT06915727?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 20 participants. The study started on 2025-04-15. Estimated completion is 2027-05-01.
What conditions does trial NCT06915727 study?
This clinical trial studies the following conditions: Malignant Pelvic Neoplasm, Childhood Malignant Solid Neoplasm, Malignant Abdominal Neoplasm, Childhood Malignant Thoracic Neoplasm, Malignant Neck Neoplasm.
What interventions are being tested in trial NCT06915727?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Surgical Procedure (PROCEDURE), Near Infrared Imaging (PROCEDURE), Pafolacianine Sodium (DRUG).
Who is sponsoring clinical trial NCT06915727?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06915727 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06915727's enrollment target sits among peer trials
20 1957th of 2000 higher than 32 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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