Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00374517
Status:
WITHDRAWN
Last Update Posted:
2017-07-02
First Post:
2006-09-08
Brief Title:
Pimonidazole Hydrochloride to Detect Low Oxygen in Tuberculosis-Infected Lungs
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase II Clinical Trial of Pimonidazole Hydrochloride as a Hypoxia Marker in Subjects Undergoing Elective Lung Resection for Treatment-Refractory Pulmonary Tuberculosis
Status:
WITHDRAWN
Status Verified Date:
2010-02-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine whether a drug called pimonidazole hydrochloride shows areas of low oxygen in tuberculosis TB-infected lungs Pimonidazole is a low oxygen marker an agent designed to find areas in the body that are not getting enough oxygen If it is found that TB grows where oxygen is low these results may help doctors decide what medicines would be most effective for treating TB
Patients 20 years of age or older who are scheduled for lung surgery at the National Masan Tuberculosis Hospital in Masan Korea to treat their TB may be eligible for this study
Participants undergo the following procedures
Blood draw before surgery to test for hepatitis B and hepatitis C viruses
Pregnancy test for women who can become pregnant
Infusion of pimonidazole through a vein in the arm 24 hours before surgery A part of the patients lung is removed during surgery This tissue is examined under a microscope for evidence of pimonidazole which would indicate low oxygen
Blood sample collection during surgery and on the 7th and 14th days after surgery to check liver function
Patients 20 years of age or older who are scheduled for lung surgery at the National Masan Tuberculosis Hospital in Masan Korea to treat their TB may be eligible for this study
Participants undergo the following procedures
Blood draw before surgery to test for hepatitis B and hepatitis C viruses
Pregnancy test for women who can become pregnant
Infusion of pimonidazole through a vein in the arm 24 hours before surgery A part of the patients lung is removed during surgery This tissue is examined under a microscope for evidence of pimonidazole which would indicate low oxygen
Blood sample collection during surgery and on the 7th and 14th days after surgery to check liver function
Detailed Description:
The purpose of this Phase II clinical trial is to establish whether pulmonary tuberculous lesions are hypoxic or contain hypoxic microenvironments using an in vivo hypoxia-imaging marker pimonidazole hydrochloride in subjects undergoing lung resection surgery for treatment-refractory pulmonary tuberculosis
The study population will be drawn from subjects undergoing treatment at the National Masan Tuberculosis Hospital NMTH Masan Republic of Korea Subjects who are scheduled for partial lung resection surgery for treatment refractory TB will be eligible for this study Selected subjects will be those who demonstrate one or more radiographic abnormalities associated with pulmonary tuberculosis eg cavities nodules consolidation fibrosis or calcified lesions
Subjects undergoing elective pulmonary resection will receive a single preoperative IV dose of pimonidazole 05 gm2 in 100 mL of normal saline infused over 20 minutes 18 to 24 hours prior to surgery The resected tissue will be analyzed to look at the following 1 the degree of pimonidazole-adduct formation in tissue specimens with different histopathologic presentations 2 the number of acid-fast bacilli in tissue sections smears or cultures prepared from homogenized lesions from distinct gross anatomic and histopathologic types in relation to the extent of tissue hypoxia and 3 comparison of lesions labeling with pimonidazole with the presence of human cellular and bacterial markers expected to be expressed under oxygen-limiting conditions NIAID study investigators will have no input of any kind in selecting subjects for surgery or in determining the kind or extent of surgical resection Subjects will be on study from a few days before surgery until approximately 8 weeks after their surgery
The study population will be drawn from subjects undergoing treatment at the National Masan Tuberculosis Hospital NMTH Masan Republic of Korea Subjects who are scheduled for partial lung resection surgery for treatment refractory TB will be eligible for this study Selected subjects will be those who demonstrate one or more radiographic abnormalities associated with pulmonary tuberculosis eg cavities nodules consolidation fibrosis or calcified lesions
Subjects undergoing elective pulmonary resection will receive a single preoperative IV dose of pimonidazole 05 gm2 in 100 mL of normal saline infused over 20 minutes 18 to 24 hours prior to surgery The resected tissue will be analyzed to look at the following 1 the degree of pimonidazole-adduct formation in tissue specimens with different histopathologic presentations 2 the number of acid-fast bacilli in tissue sections smears or cultures prepared from homogenized lesions from distinct gross anatomic and histopathologic types in relation to the extent of tissue hypoxia and 3 comparison of lesions labeling with pimonidazole with the presence of human cellular and bacterial markers expected to be expressed under oxygen-limiting conditions NIAID study investigators will have no input of any kind in selecting subjects for surgery or in determining the kind or extent of surgical resection Subjects will be on study from a few days before surgery until approximately 8 weeks after their surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-I-N241 | None | None | None |