Tc-99m Renography and Cisplatin-induced Nephrotoxicity

This study has been terminated.
Sponsor:
Collaborator:
Ligue contre le cancer, France
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00213642
First received: September 13, 2005
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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
Cancer
Drug Toxicity
Kidney Failure

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Value of Tc-99m Renography for Early Diagnosis of Cisplatin-induced Renal Toxicity

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Estimated Enrollment: 20
Study Start Date: July 2001
Estimated Study Completion Date: August 2004
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00213642

Sponsors and Collaborators
University Hospital, Rouen
Ligue contre le cancer, France
Investigators
Study Chair: Alain Manrique, MD University Hospital, Rouen
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00213642     History of Changes
Other Study ID Numbers: 2000/003/HP
Study First Received: September 13, 2005
Last Updated: June 17, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Rouen:
Technetium Tc 99m Mertiatide
Radionuclide Imaging
Cisplatin
Kidney failure
Drug Toxicity
Cancer

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Cisplatin
Antineoplastic Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014