Phase 3 Head and Neck Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• The patient (or their parent or legal guardian) is willing and able to give written consent to participate
• The patient is between 6 months and 17 years of age
• The patient has been diagnosed with, or is strongly suspected to have, a solid tumour located in the neck, chest, abdomen, pelvis, or limbs, and surgery is planned — this may include tumour types such as sarcomas, carcinomas, germ cell tumours, or other solid tumours (note: the exact tumour type does not need to be confirmed before surgery)

Who may not be able to join:

• The patient has previously received the drug Cytalux™ (pafolacianine)
• The patient has a medical condition that the study doctors believe could put them at risk during the trial
• The patient has a history of a severe allergic reaction (anaphylaxis) to products containing indocyanine green, a dye used in medical imaging — patients with a history of unexplained severe allergic reactions will need further evaluation (confirm with trial site)
• The patient has a known allergy to any ingredient in Cytalux™ (pafolacianine)
• There are psychological, family, social, or geographical circumstances that may make it difficult to follow the study plan or attend follow-up appointments
• The patient has received an experimental drug or vaccine as part of another research trial within the last 30 days — note that trials using already FDA-approved drugs or vaccines, such as Children's Oncology Group studies, are generally acceptable (confirm with trial site)
• The patient has a known sensitivity to fluorescent (bright) light
• The patient is pregnant
• The patient is unwilling or unable to stop taking folic acid, folate supplements, or multivitamins containing folate for 48 hours before receiving the study drug
• The patient has severely reduced kidney function or is on dialysis — specific kidney function thresholds apply depending on age (confirm with trial site)
• The patient is being assessed for liver failure or is listed for a liver transplant — patients with a specific liver condition called Gilbert's syndrome may also be excluded if their liver function test results are significantly abnormal (confirm with trial site)
• The patient is unwilling or unable to use appropriate contraception or avoid sexual activity for 30 days after receiving the study drug
• The patient plans to donate eggs or sperm within 30 days after receiving the study drug

Important: Always verify eligibility with the trial site directly before applying.