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

November 28, 2013 updated by: Carmel Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

5

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 34362
        • Recruiting
        • Department of Otolaryngology, Carmel Medical Center
        • Contact:
        • Principal Investigator:
          • Raanan Cohen-Kerem, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OK432
Intracystic injection of OK432 under US guiding
Drug: Intracystic injection of OK432 under US guiding
Intracystic injection of OK432 under US guiding
Other Names:
  • OK432 (Picibanil)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
TREATMENT SAFETY BY no. of participants with adverse events
Time Frame: 4 YEARS
4 YEARS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carmel Medical Center

Investigators

  • Principal Investigator: Raanan Cohen-Kerem, MD, Carmel Medical Center, Haifa, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

January 1, 2014

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

August 19, 2012

First Submitted That Met QC Criteria

September 30, 2012

First Posted (Estimate)

October 3, 2012

Study Record Updates

Last Update Posted (Estimate)

December 2, 2013

Last Update Submitted That Met QC Criteria

November 28, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMC-11-0059-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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