Tc-99m Renography and Cisplatin-induced Nephrotoxicity

June 17, 2013 updated by: University Hospital, Rouen

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

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment

20

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Collaborators and Investigators

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

Sponsor

University Hospital, Rouen

Collaborators

Ligue contre le cancer, France

Investigators

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

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

July 1, 2001

Study Completion

August 1, 2004

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

June 18, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000/003/HP

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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