PLEASE NOTE: MEDICINAL PRODUCT NO LONGER AUTHORIZED
What is NeoSpect?
NeoSpect is a kit for the preparation of a radiolabelled medicine. NeoSpect consists of a white powder containing the active substance depreotide which is used to prepare a solution for injection.
What is NeoSpect used for?
NeoSpect is not used on its own but must be radiolabeled before use. Radiolabeling is a technique used to mark (mark) a substance with a radioactive compound. NeoSpect is radiolabelled by mixing it with a solution of radioactive technetium (99mTc).
The radiolabelled drug is used for diagnostic purposes. NeoSpect is used for patients with a solitary pulmonary nodule (small, rounded lesion in the lungs) detected by CT (computed tomography) or chest x-ray to determine if it is malignant (i.e., cancer).
The medicine can only be obtained with a prescription.
How is NeoSpect used?
NeoSpect should only be handled and administered by personnel specialized and experienced in the techniques of safe handling of radioactive materials. NeoSpect is reconstituted into a radiolabelled solution for administration by intravenous injection (into a vein); the diagnostic image should be obtained 2-4 hours after the injection. As a rule, it should not be used more than once in the same patient.
How does NeoSpect work?
The active substance in NeoSpect, depreotide, is a somatostatin analog. This means that it acts like somatostatin and binds to the same receptors in the body as somatostatin. These receptors are present in large numbers in some types of malignancy, such as lung cancers. Once NeoSpect has been radiolabelled, the " radioactive element technetium 99m (99mTc) joins depreotide. Since depreotide binds to receptors, it carries with it the radioactive element which can thus be detected with the use of special diagnostic imaging tools, for example by scintigraphy or SPECT (single photon emission computed tomography). Any marking of the solitary pulmonary node with NeoSpect indicates probable malignancy. Otherwise, the nodule will probably be benign (non-malignant).
How has NeoSpect been studied?
NeoSpect has been studied in two main studies involving 258 patients with suspected lung cancer. Patients underwent CT or chest X-ray as well as SPECT with radiolabelled NeoSpect. The outcome of the examination with NeoSpect was compared with the actual diagnosis based on the histological examination of the nodule (microscopic analysis of the surgically removed nodule tissue). The main parameter of effectiveness was the accuracy of the diagnosis of malignancy. (positive outcome) or benignity (negative outcome) of the tumor.
What benefit has NeoSpect shown during the studies?
The result of the examination carried out with NeoSpect was confirmed by the histological examination in 80-90% of cases. The association of the radiodiagnostic examination with NeoSpect and a CT scan increased the specificity of the examination, facilitating the physician's diagnosis of malignancy of the nodule.
What is the risk associated with NeoSpect?
Side effects associated with NeoSpect are rare; the relatively most frequent ones (seen in 1 to 10 out of 1000 patients) are headache, nausea, vomiting, diarrhea, abdominal pain, dizziness, redness and fatigue (tiredness).
NeoSpect should not be used in patients who may be hypersensitive (allergic) to depreotide, sodium pertechnetate or any of the other ingredients. NeoSpect should not be used in pregnant or breastfeeding women.
Why has NeoSpect been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that NeoSpect's benefits are greater than its risks for the "scintigraphic examination of lung tumors of suspected malignancy after initial detection, in combination with CT scan or chest X-ray, in patients with nodules. solitary lungs, and therefore recommended the release of the "marketing authorization" of the product.
More information about NeoSpect:
On November 29, 2000, the European Commission issued a "Marketing Authorization" for NeoSpect, valid throughout the European Union. The "Marketing Authorization" was renewed on November 29, 2005. The Marketing Authorization Holder "placing on the market is CIS bio international.
For the complete version of the NeoSpect EPAR click here.
Last update of this summary: 09-2007.
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