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Tc-99m Renography and Cisplatin-induced Nephrotoxicity

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ClinicalTrials.gov Identifier: NCT00213642
Recruitment Status : Terminated
First Posted : September 21, 2005
Last Update Posted : June 18, 2013
Ligue contre le cancer, France
Information provided by (Responsible Party):
University Hospital, Rouen

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
Cancer Drug Toxicity Kidney Failure

Study Type : Observational
Estimated Enrollment : 20 participants
Time Perspective: Prospective
Official Title: Value of Tc-99m Renography for Early Diagnosis of Cisplatin-induced Renal Toxicity
Study Start Date : July 2001
Estimated Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00213642

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

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00213642     History of Changes
Other Study ID Numbers: 2000/003/HP
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: June 18, 2013
Last Verified: June 2013

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

Additional relevant MeSH terms:
Renal Insufficiency
Drug-Related Side Effects and Adverse Reactions
Kidney Diseases
Urologic Diseases
Chemically-Induced Disorders
Antineoplastic Agents