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AN-Dtpa (Technetium Tc 99m Pentetate Calcium Trisodium) - Summary



AN-DTPA® Kit for the Preparation of
Technetium Tc 99m Pentetate Injection
Diagnostic For Intravenous Use

AN-DTPA Kit for the Preparation of Technetium Tc 99m Pentetate Injection is a multidose reaction vial which contains the sterile, non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Pentetate Injection for diagnostic use by intravenous injection. Each 10 mL reaction vial contains 20.6 mg pentetate calcium trisodium, 0.15 mg minimum stannous tin as stannous chloride dihydrate and 0.30 mg maximum total tin as stannous chloride dihydrate in lyophilized form and sealed under nitrogen. The pH is adjusted to 3.9-4.1 with sodium hydroxide and/or hydrochloric acid prior to lyophilization. No bacteriostatic preservative is present. The active agent is a Technetium Tc 99m complex of pentetate calcium trisodium.

AN-DTPA (Pentetate Calcium Trisodium) is indicated for the following:

Technetium Tc 99m Pentetate Injection may be used to perform kidney imaging, brain imaging, to assess renal perfusion and to estimate glomerular filtration rate.

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Published Studies Related to AN-Dtpa (Technetium Tc 99m Pentetate)

Effect of hydroxyurea treatment on renal function parameters: results from the multi-center placebo-controlled BABY HUG clinical trial for infants with sickle cell anemia. [2012]
CONCLUSION: Treatment with hydroxyurea for 24 months did not influence GFR in

Hydroxycarbamide in very young children with sickle-cell anaemia: a multicentre, randomised, controlled trial (BABY HUG). [2011.05.14]
BACKGROUND: Sickle-cell anaemia is associated with substantial morbidity from acute complications and organ dysfunction beginning in the first year of life. Hydroxycarbamide substantially reduces episodes of pain and acute chest syndrome, admissions to hospital, and transfusions in adults with sickle-cell anaemia. We assessed the effect of hydroxycarbamide therapy on organ dysfunction and clinical complications, and examined laboratory findings and toxic effects... INTERPRETATION: On the basis of the safety and efficacy data from this trial, hydroxycarbamide can now be considered for all very young children with sickle-cell anaemia. FUNDING: The US National Heart, Lung, and Blood Institute; and the National Institute of Child Health and Human Development. Copyright (c) 2011 Elsevier Ltd. All rights reserved.

A randomized crossover study of the effects of glutamine and lipid on the gastric emptying time of a preoperative carbohydrate drink. [2011.04]
BACKGROUND & AIMS: Supplementing preoperative carbohydrate drinks with glutamine may lead to benefits in addition to reducing insulin resistance, but amino acids may delay gastric emptying (GE). The effects of supplementing a preoperative carbohydrate drink (CCD) with glutamine or lipid on GE were studied... CONCLUSIONS: Glutamine and lipid supplementation did not prolong the GE of CCD but did 'blunt' postprandial glucose and insulin responses, independent of GLP-1 concentrations. Registered under ClinicalTrials.gov Identifier no. NCT00943020. Copyright (c) 2010 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

In-vitro and in-vivo erosion profiles of hydroxypropylmethylcellulose (HPMC) matrix tablets. [2010.10.01]
The purpose of this study was to evaluate and compare the in-vitro and in-vivo erosion profiles of two tablet formulations primarily consisting of hydroxypropylmethylcellulose (HPMC) and lactose. HPMC was used at concentrations below and above the reported values for polymer percolation threshold in controlled release matrix formulations: 20 and 40% (w/w) HPMC.

Assessment of levetiracetam bioavailability from targeted sites in the human intestine using remotely activated capsules and gamma scintigraphy: Open-label, single-dose, randomized, four-way crossover study in healthy male volunteers. [2010.09]
BACKGROUND: Levetiracetam is a broad-spectrum antiepileptic drug that binds to synaptic vesicle protein SV2A. Levetiracetam is indicated in the adjunctive treatment of partial-onset seizures, myoclonic seizures, and generalized tonic-clonic seizures. It is also approved in Europe as monotherapy for newly diagnosed partial-onset seizures. A Phase I clinical pharmacology trial was conducted during preregistration clinical development to better understand the regional gastrointestinal (GI) absorption of levetiracetam. OBJECTIVE: This study evaluated the relative bioavailability of levetiracetam in various regions of the GI tract using a noninvasive, remote-controlled capsule device providing targeted drug delivery, relative to that after oral administration, and explored the drug's absorption characteristics in healthy volunteers... CONCLUSION: After delivery in the proximal small bowel, distal small bowel, or ascending colon, the systemic bioavailability of levetiracetam (AUC), but not C(max) and T(max), appeared comparable to that after oral administration and thus appeared site independent in this small group of healthy fasting men. Copyright A(c) 2010 Excerpta Medica Inc. All rights reserved.

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Clinical Trials Related to AN-Dtpa (Technetium Tc 99m Pentetate)

SPECT/CT in Measuring Lung Function in Patients With Lung Cancer Undergoing Radiation Therapy [Recruiting]
This pilot clinical trial studies single photon emission computed tomography (SPECT)/computed tomography (CT) in measuring lung function in patients with lung cancer undergoing radiation therapy. Diagnostic procedures that measure lung function may help doctors find healthy lung tissue and allow them to plan better treatment.

A Pharmacodynamic Study of Measured Glomerular Filtration Rate in Patients With Chronic Kidney Disease and Type 2 Diabetes [Terminated]
This is a 24-week multi-center, double-blind, randomized, exploratory study of bardoxolone methyl treatment in 18 patients with Stage 3 CKD (eGFR greater than or equal to 30. 0 to less than 60. 0 ml/min/1. 73m2) and diabetes to ensure at least 15 patients complete the study for evaluation of the primary endpoints.

Effect of Seminal Fluid on the Colon Wall; Implications for HIV Transmission [Completed]
This research is being done to learn how seminal fluid affects the lining of the colon, and whether this might make it easier for HIV to get into the body and cause infection.

Tenofovir Renal Toxicity and Glomerular Filtration Rate (GFR) Validation [Active, not recruiting]

Medical and Endovascular Treatment of Atherosclerotic Renal Artery Stenosis (METRAS Study) [Not yet recruiting]
Renal atherosclerotic stenosis (RAS) is a prevalent cause of secondary hypertension (HT). Since there are still uncertainties as to whether and in what patients revascularization by means of percutaneous renal angioplasty (PTRAS) should be pursued, we designed a study exploiting an optimized patient selection strategy and using hard experimental endpoints to unravel these uncertainties. Primary objective: to determine if revascularization by means of PTRAS is superior or equivalent to optimal medical treatment for preserving glomerular filtration rate in the ischemic kidney as assessed by 99mTcDTPA sequential renal scintiscan. Secondary objectives: to determine if the two treatments are equivalent in lowering blood pressure (BP), preserving overall renal function and regressing damage in the target organs of hypertension. Design: prospective multicenter randomized, unblinded two-arm study. Eligible patients will have clinical and/or radiological evidence of unilateral or bilateral RAS, defined by stenosis of the proximal portion of the renal artery and its main bifurcations at angioCT. Duplex scan will exclude nephroangiosclerosis as the latter could bias the assessment of the outcome of revascularization. Inclusion criteria. RAS affecting the main renal artery or its major branches at angio-CT either > 70% or, if < 70 with post-stenotic dilatation. Renal function will be assessed with 99mTc-DTPA renal scintigraphy. Sample size (30 patients per arm) was calculated to have a 90% power to detect a difference in means of GFR in the vascularized (or control untreated kidney) of 7. 5 ml/min. Arms 1. Revascularization: digital scan angiography and PTA with stenting of the renal artery at the ostium or at truncular level, plus optimal medical therapy. 2. Medical therapy: the drug regimen that had been optimized during the run-in period. Experimental endpoints: The absolute value of GFR assessed by 99TcDTPA in the ischemic kidney will be used as quantitative variable and compared between groups at each time point. A categorical definition of kidney loss, defined as a GFR in the ischemic kidney of < 5 ml/min, will be also used and the rate of achievement of such endpoint will be compared. Duration: 5 years.

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Page last updated: 2013-02-10

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