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| ID | Type | Description | Link |
|---|---|---|---|
| 24-012249 | Other Identifier | Mayo Clinic Institutional Review Board |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (pafolacianine + NIR) | Experimental | Patients receive pafolacianine IV over 60 to 90 minutes and undergo NIR fluorescent imaging during standard of care (SOC) surgery on study. Patients also undergo collection of tissue during SOC surgery on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo tissue sample collection |
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| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Cytaluxâ„¢ (pafolacianine) injection used with NIR fluorescent imaging for detecting lesions | Each excised specimen will be analyzed for histologic findings to determine accuracy of Cytaluxâ„¢ (pafolacianine) injection used with near infrared (NIR) fluorescent imaging for detecting lesions. Accuracy will be assessed using sensitivity and specificity. | Up to 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time between Cytaluxâ„¢ administration and NIR imaging detection intraoperatively | Descriptive statistics will be performed and descriptive summaries such as mean (standard deviation) or median (minimum, maximum) for continuous variables and frequencies and percentages for categorical variables will be reported. | Day 0 to 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu | |
| Gina Lewis | Contact | 507-284-0850 | DOSCRO2@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Stephanie F. Polites, MD, MPH | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Near Infrared Imaging | Procedure | Undergo NIR fluorescent imaging |
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| Pafolacianine Sodium | Drug | Given IV |
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| Surgical Procedure | Procedure | Undergo SOC surgery |
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| Reasons for not excising NIR avid lesions |
Descriptive statistics will be performed and descriptive summaries such as mean (standard deviation) or median (minimum, maximum) for continuous variables and frequencies and percentages for categorical variables will be reported. All tests will be two sided and p-values less than 0.05 will be considered statistically significant. |
| Day 0 to 1 |
| Incidence of Adverse Events surgery | Cytaluxâ„¢ (pafolacianine) will be assessed for safety in children and adolescent patients undergoing by the number and severity of adverse events (AEs), defined as events (serious or non-serious) of scientific and medical concern specific to the investigational product and/or the combination of products being used in a study. AEs will be assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5. | From study enrollment up to 30 days after surgery |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D010386 | Pelvic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| C000720187 | Pafolacianine |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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