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

AN-DTPA 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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NEWS HIGHLIGHTS

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

Positive expiratory pressure changes aerosol distribution in patients with cystic fibrosis. [2005.11]
HYPOTHESIS: We hypothesized that aerosol distribution in the lungs of patients with cystic fibrosis changes with positive expiratory pressure (PEP)... CONCLUSION: These results indicate that less aerosol is deposited in the lungs of patients with cystic fibrosis when the Pari LC Plus nebulizer is used with the Pari PEP device, as described in these experiments. Nevertheless, aerosol administration with this nebulizer and PEP device also results in a proportional redistribution of aerosol to the peripheral airways, compared to nebulization without the PEP device. The clinical relevance of this subtle redistribution of aerosol in cystic fibrosis patients will probably depend on the drug administered and disease severity.

Diagnostic evaluation of planar and tomographic ventilation/perfusion lung images in patients with suspected pulmonary emboli. [2004.09]
Planar lung ventilation/perfusion scintigraphy (V/P(PLANAR)) is a standard method for diagnosis of pulmonary embolism (PE). The goals of this study were to test whether the diagnostic information of ventilation/perfusion tomography (V/P(SPET)) applied in clinical routine might enhance information compared with V/P(PLANAR) and to streamline data processing for the demands of clinical routine...

Comparative study of renal function between standard and modified anatrophic nephrolithotomy by radionuclide renal scans. [2004.06]
CONCLUSION: The average operative time of sANL was longer than mANL however, sANL preserved more renal function than mANL. This study suggested that sANL should be the procedure of choice in patients who have compromised renal function.

In vitro and in vivo pharmacoscintigraphic evaluation of ibuprofen hypromellose and gelatin capsules. [2004.05]
PURPOSE: To evaluate the in vitro and in vivo characteristics of hypromellose (HPMC) capsules prepared using a gellan gum and potassium gelling system compared to conventional hard gelatin capsules... CONCLUSIONS: The in vitro performance of HPMC capsules differ from gelatin, which will require modification to dissolution testing methodology for certain drugs. However, for the class II BCS drug ibuprofen, the two capsule types were not statistically different when comparing AUC and C(max) values, which suggests that the in vitro differences have reduced in vivo relevance.

Retention and distribution of two 99mTc-DTPA labelled vaginal dosage forms. [2004.03.01]
CONCLUSIONS: Radioactive tracer methods are useful in assessing and comparing vaginal dosage forms.

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

Determination of Kidney Function [Recruiting]
Much more about kidney disorders can be learned by determining kidney function. This research proposes to study the kidneys function by several parameters known as glomerular filtration rate (GFR), Renal Plasma Flow (RPF), and Glomerular Capillary Wall Permselectivity.

The study will select patients suffering from different types of kidney diseases. These patients will be selected based on the presence of significant amounts of protein in their urine (proteinuria).

Standard blood and urine tests are often unable to provide completely accurate information about the kidney. In order for researchers to have a more accurate idea of kidney function, they will use alternative tests. Test materials (para aminohippurate and inulin) will be injected into patients veins that provides information based on their filtration through the kidneys.

Cardiopulmonary Function Assessment and NO-Based Therapies for Patients With Hemolysis-Associated Pulmonary Hypertension [Recruiting]
This study will evaluate new treatments for people who have pulmonary hypertension, or high blood pressure in the lungs, caused by sickle cell anemia or thalassemia.

Patients ages 18 and older with a diagnosis of sickle cell disease or thalassemia, who have mild to severe pulmonary hypertension, and who are not pregnant or breastfeeding may be eligible for this study. There are three stages in the study, with up to 200 participants in the screening. Patients will undergo pulmonary function tests, including those for asthma and measurement of oxygen levels in the arterial blood. They will have a chest X-ray, computed tomography (CT) scan of the lungs, ventilation perfusion lung scan to look for blood clots, echocardiogram, test to measure how far patients can walk in 6 minutes, nighttime oxygen measurement done while asleep, blood collection, magnetic resonance imaging (MRI) scan of the heart, and exercise test. About 3 to 4 days are needed for the tests, all of which can be done while patients are outpatients, except for the sleep study. For the CT scan, patients lie on a table while an X-ray beam takes images of the lungs and heart. The lung scan involves breathing of a small amount of a radioactive aerosol called Tc99m DTPA while pictures are taken of the lungs from various angles. Then an injection of albumin, a protein with a small amount of radioactivity, will be given, and more lung pictures will be taken. For the MRI scan, patients lie on a table that slides into a machine. A medication called gadolinium will be injected, to help improve images made through the scan. After the tests, patients will be admitted to the Clinical Center for 1 day. A small plastic catheter, or tube, will be placed in the vein of an arm. A longer catheter will go into a deeper vein (neck or leg), and a pulmonary artery catheter will be inserted to measure blood pressure in the blood vessels. Doctors will guide the catheter into the lung artery. Patients will be asked to pedal on a stationary bicycle while heart and lung pressure is measured. If pulmonary hypertension is present, patients will proceed to the second stage (up to 50 participants). While the catheter is still in place, patients will wear a face mask and breathe nitric oxide (NO) for 20 minutes. They will take 50 mg of sildenafil by mouth, and pressure in the heart and lungs will be monitored for about 4 hours. They will again receive NO for another 20 minutes. Blood samples will be taken, and the heart rhythm and pressure in the lungs will be monitored. Sildenafil can cause headache, flushing, and indigestion. Side effects of the lung scan involve allergic reactions to DTPA and albumin. Patients with an allergy to eggs should not have that test.

Up to 25 patients can enter the third stage. They will breathe NO by using a tank of gas that delivers it through tubes to the nose, for a period of 6 weeks. They will continue taking sildenafil as previously prescribed and visit the clinic every 2 to 4 weeks for an echocardiogram, blood tests, and 6-minute walk test. After 6 weeks, patients will have catheterization of the heart again to measure pressure in the heart and lungs. Then NO will be stopped, and pressure in the lungs will be checked to see if NO has helped lower the blood pressure-and to make sure that the blood pressure does not increase when medication is stopped. Patients whose symptoms have improved as a result of breathing NO may wish to continue with that therapy.

Adrenal Scans With Radioiodine-Labeled Norcholesterol (NP-59) [Recruiting]
The purpose of this study is to find out if your adrenal glands are normal or abnormal. This can be determined by whether or not your adrenal gland concentrates more of a labeled building block of adrenal hormone, norcholesterol. This labeled material had been used as an investigative diagnostic tool for imaging adrenal glands for many years with success in our hands. This is a diagnostic procedure. CT, MRI and Ultrasound can determine the size and presence or absence of tumor but cannot assess the function of the adrenal glands. To determine hormone concentrations from blood samples would involve more invasive catherization.

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