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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01699347

Acronym

OK432

Enrollment

Registered

2012-10-03

Start date

2012-09-30

Completion date

2016-01-31

Last updated

2013-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CYSTIC MALFORMATION

Keywords

OK432, CYSTIC MALFORMATION

Brief summary

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.

Detailed 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

Interventions

DRUGIntracystic injection of OK432 under US guiding

Intracystic injection of OK432 under US guiding

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 18 Years

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

Design outcomes

Primary

Measure	Time frame
evaluation of the efficacy in treating cystic malformation with OK432 by measuring time that elapsed without recurrence	4 years

Secondary

Measure	Time frame
TREATMENT SAFETY BY no. of participants with adverse events	4 YEARS

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026