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Tc-99m Renography and Cisplatin-induced Nephrotoxicity

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00213642
Enrollment
20
Registered
2005-09-21
Start date
2001-07-31
Completion date
2004-08-31
Last updated
2013-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Drug Toxicity, Kidney Failure

Keywords

Technetium Tc 99m Mertiatide, Radionuclide Imaging, Cisplatin, Kidney failure, Drug Toxicity, Cancer

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.

Interventions

None listed

Sponsors

Ligue contre le cancer, France
CollaboratorOTHER
University Hospital, Rouen
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026