Tc-99m Renography and Cisplatin-induced Nephrotoxicity

Sponsor

University Hospital, Rouen (Other)

Overall Status

Terminated

CT.gov ID

NCT00213642

Collaborator

Ligue contre le cancer, France (Other)

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

Cisplatin is a heavy-metal complex widely used in the treatment of a variety of malignancies, including small cell and non-small cell lung cancer, ovarian, bladder, head and neck, esophageal, cervical and germ cell tumors. The administration of cisplatin is commonly associated with certain drug-induced toxicities that may limit their clinical utility and adversely affect the quality of life of patients undergoing treatment. Although many advances have been made in reducing some of the toxicities associated with platinum drug therapy, it is clear that dose-limiting nephrotoxicity remains a major stumbling block in the use of this compound. Subtle changes in renal function occur without overt renal insufficiency, consisting of a decrease in effective renal plasma flow and tubular dysfunction despite aggressive hydratation. Early tubular damage occurring within 1 to 3 hours after cisplatin administration has been demonstrated by measurement of urinary beta 2-microglobulin, a sensitive marker of tubular injury. The chronic lesion has become of greater concern in recent years as many patients have been cured or placed into long-term remission due to cisplatin treatment. It consists of a decrease in glomerular filtration rate, which is not necessary characterized by a remarkable increase in serum creatinine. Cumulative tubular damage has been demonstrated by increased urinary excretion of tubular enzymes such as alanine aminopeptidase and beta 2-microglobulin. In this setting, predicting the occurrence of chronic cisplatin-induced nephrotoxicity remains a clinical challenge.

Tc-99m mercaptoacetyltriglycine (MAG3) is predominantly a proximal tubular secretion renal agent without cortical fixation indicated for dynamic renal studies to evaluate cortical tubular function and collecting system drainage. Tc-99m MAG3 and is the agent of choice for obstructive uropathy and diffuse functional abnormalities of the renal cortex. The aim of this study was to evaluate by means of Tc-99m MAG3 scintigraphy the acute and subacute impairment of tubular secretion after cisplatin administration in patients with head and neck cancer receiving chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Cancer Drug Toxicity Kidney Failure

Study Design

Study Type:

Observational

Time Perspective:

Prospective

Official Title:

Value of Tc-99m Renography for Early Diagnosis of Cisplatin-induced Renal Toxicity

Study Start Date :

Jul 1, 2001

Study Completion Date :

Aug 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with head and neck cancer
Receiving a chemotherapy including cisplatin administration (>80 mg/m2)
WHO score < or = 2
Estimated life expectancy > 6 month
Normal renal function
Signed informed consent

Exclusion Criteria:

Congestive heart failure
History of cisplatin treatment
Metastatic carcinoma
History of radiation therapy
History of renal insufficiency
History of chronic renal disease
Pregnancy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Rouen
Ligue contre le cancer, France

Investigators

Study Chair: Alain Manrique, MD, University Hospital, Rouen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Rouen

ClinicalTrials.gov Identifier:

NCT00213642

Other Study ID Numbers:

2000/003/HP

First Posted:

Sep 21, 2005

Last Update Posted:

Jun 18, 2013

Last Verified:

Jun 1, 2013

Keywords provided by University Hospital, Rouen

Technetium Tc 99m Mertiatide

Additional relevant MeSH terms:

Renal Insufficiency

Study Results

No Results Posted as of Jun 18, 2013