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New treatment option for Childhood Malignant Solid Neoplasm
Official title An Imaging Agent (Pafolacianine) for Identifying Lesions in Pediatric Patients With Primary or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06915727
What this study is testing
What is Pafolacianine Sodium?
Pafolacianine Sodium is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for childhood malignant solid neoplasm.
Also referred to as Cytalux.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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...
- Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to the administration of the study drug...
See the full eligibility criteria
- 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...
- 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...
- 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) \ 2x the upper limit of normal will serve as an exclusion criteria. Creatinine will be measured by enzymatic assay with calibration traceable to...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.