Cohort Prospective Study of Children With Head and Neck Cystic Malformation Who Are Treated With Intracystic OK432

Israel Healthcare Foundation

Status and phase: Unknown; Phase 4

Conditions: CYSTIC MALFORMATION

Treatments: Drug: Intracystic injection of OK432 under US guiding

Study type: Interventional

Funder types: Other

Identifiers

NCT01699347

CMC-11-0059-CTIL

Details and patient eligibility

About

Cohort study evaluate the efficacy treatment with OK-432 in cystic malformation of the head and neck region.

The malformations are macrocystic and the preevaluation will include CT/MRI, US and blood tests.

The injection will be in the OR under US guided, maximal dose will be 0.2mg. The follow-up will be of short term - till 30 days post injection and long term - follow-up wil be till 2 years.

Full description

A cohort study, before the injection all the patients in the study will go through:

1. CT/MRI
2. US to estimate the cyst size
3. CBC, PT, PTT, INR, ASLO
4. ECG If the patient is qualified to the study the parent will sign on the inform consent, than the child will be photographed AP and lateral.

The injection will be held in the OR under US guidance with 18q20 gauge needle, first all the cyst contents will be sucked than the OK432 will be injected in.

After the injection the child will stay for one night if it was general anesthesia and 4 hours in the case of local anesthesia.

Short term follow - 3-5 days with the phone, up: till 30 days from the injection with US, stills photo.

Long term follow-up: 6 months, 1 year, 2 years

Enrollment: 5 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• LYMPHATIC MALFORMATION MACROCYSTIC OR MIXED WITH MORE THEN 50% MACROCYSTIC.
• ONLY IN THE HEAD AND NECK AREA
• TIME FROM OPERATION AT LEAST 6 MONTHS

Exclusion criteria

• penicillin allergy
• pregnancy
• familial history of RF
• Post streptococcal glomerulonephritis
• Background illness-heart, kidney, lungs
• fever > 38.5c in the op day
• URT Infection
• Family history of PANDAS

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

OK432

Experimental group

Description:

Intracystic injection of OK432 under US guiding

Treatment:

Drug: Intracystic injection of OK432 under US guiding