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

CYSTIC MALFORMATION Clinical Trial

— OK432  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01699347
• Other study ID #: CMC-11-0059-CTIL
• Status: Recruiting
• Phase: Phase 4
• First received: August 19, 2012
• Last updated: November 28, 2013
• Start date: September 2012
• Est. completion date: January 2016

Study information

• Verified date: November 2013
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: January 2016
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Abnormalities
• CYSTIC MALFORMATION

Intervention

Drug:
• Intracystic injection of OK432 under US guiding
Intracystic injection of OK432 under US guiding

Locations

Country	Name	City	State
Israel	Department of Otolaryngology, Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluation of the efficacy in treating cystic malformation with OK432 by measuring time that elapsed without recurrence		4 years	Yes
Secondary	TREATMENT SAFETY BY no. of participants with adverse events		4 YEARS	Yes