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Childhood Malignant Solid NeoplasmPhase 3NCT06915727

An Imaging Agent (Pafolacianine) for Identifying Lesions in Pediatric Patients With Primary or Metastatic Solid Tumors

A Phase 3 study testing Biospecimen Collection, Near Infrared Imaging and Pafolacianine Sodium in people with Childhood Malignant Solid Neoplasm and Childhood Malignant Thoracic Neoplasm, run by Mayo Clinic at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 6 months to 17 years
What is being tested?
Biospecimen Collection, Near Infrared Imaging and Pafolacianine Sodium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
15 Apr 2025to 1 May 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Willingness of research participant or legal guardian/representative to give written informed consent
  • Age 6 months to 17 years
  • Have a diagnosis, or a high clinical suspicion, of a solid tumor in the neck, chest, abdomen, pelvis, or extremities with a plan for surgical resection including embryonal tumors, sarcomas, neurogenic tumors, carcinomas, mesenchymal tumors, germ cell tumors. Children may undergo surgical resection or biopsy of a solid tumor that is suspected to be malignant without a separate preoperative biopsy; therefore, the tumor type may not be definitively known preoperatively

Who cannot join

  • Previous exposure to Cytalux™ (pafolacianine) injection
  • Any medical condition that in the judgement of the investigators could potentially jeopardize the safety of the participant
  • History of anaphylactic reactions to products containing indocyanine green for near infrared imaging. Participants with a medical history of 'idiopathic anaphylaxis' will require evaluation
  • History of allergy to any of the components of Cytalux™ (pafolacianine) injection
  • Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule
  • Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to the administration of the study drug. Investigational trials involving administration of drugs or vaccines which are already Food and Drug Administration (FDA)-approved, such as Children's Oncology Group cooperative trials, are okay
Show all 13Show fewer
  • Known sensitivity to fluorescent light
  • Pregnancy
  • Unable or unwilling to discontinue folic acid, folate supplements, and multi-vitamins containing folate 48 hours prior to drug administration
  • Renal failure on dialysis or estimated glomerular filtration rate (eGFR) < 30 mL/min/1.72m^2 as measured by the U25 eGFR equation for patients ≥1 year(s) of age. For patients < 1 year of age, creatinine > 2x the upper limit of normal will serve as an exclusion criteria. Creatinine will be measured by enzymatic assay with calibration traceable to the international standard reference materials and minimal bias compared to isotope-dilution mass spectrometry (IDMS) reference methodology.
  • Undergoing workup for liver failure or listed for liver transplant. Patients with Gilbert's syndrome will be excluded if impaired liver function defined as values > 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin
  • Unable or unwilling to use adequate birth control/contraceptive measures or abstain from sexual activity for 30 days following the study intervention
  • Anticipated need to donate ova or sperm within 30 days following study intervention

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Referral Office contact

855-776-0015

mayocliniccancerstudies@mayo.edu

Gina Lewis contact

507-284-0850

DOSCRO2@mayo.edu

United States1 site, 1 recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Gina Lewis, 507-284-0850, DOSCRO2@mayo.edu

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    Recruiting

Other trials in United States

About this study

Official title: Pafolacianine for Localization of Pediatric Extracranial 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 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.

Being tested
Biospecimen Collection, Near Infrared Imaging, Pafolacianine Sodium, Surgical Procedure
Medical subject headings
Head and Neck Neoplasms, Pelvic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo tissue sample collection

  • Near Infrared ImagingProcedure or surgery

    Also called Near-Infrared Imaging, NIR Imaging

    Undergo NIR fluorescent imaging

  • Pafolacianine SodiumDrug

    Also called Cytalux

    Given IV

  • Surgical ProcedureProcedure or surgery

    Also called Operation, Surgery, Surgery Type, Surgery, Not Otherwise Specified (NOS)

    Undergo SOC surgery

Study groups in NCT06915727
Study groupRoleWhat they receive
Diagnostic (pafolacianine + NIR)ExperimentalPatients 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.
Receives: Procedure: Biospecimen Collection; Procedure: Near Infrared Imaging; Drug: Pafolacianine Sodium; Procedure: Surgical Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accuracy of Cytalux™ (pafolacianine) injection used with NIR fluorescent imaging for detecting lesions

    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.

    Measured: Up to 30 days after surgery

Secondary outcomes (3)

  1. Time between Cytalux™ 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.

    Measured: Day 0 to 1

  2. 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.

    Measured: Day 0 to 1

  3. Incidence of Adverse Events surgery

    Cytalux™ (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.

    Measured: From study enrollment up to 30 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2025
  2. Study start15 Apr 2025
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06915727
Sponsor's protocol ID
MC250701
Other IDs
24-012249
Status last verified
Mar 2026
First submitted
28 Mar 2025
Last updated
1 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Biospecimen Collection, Near Infrared Imaging and Pafolacianine Sodium in people with Childhood Malignant Solid Neoplasm and Childhood Malignant Thoracic Neoplasm, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy of Cytalux™ (pafolacianine) injection used with NIR fluorescent imaging for detecting lesions (time frame: Up to 30 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06915727.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.

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