PLEASE NOTE: MEDICINAL PRODUCT IS 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 alone but must be radiolabelled before use. Radiolabelling is a technique used to mark (mark) a substance through a radioactive compound. NeoSpect is radiolabelled by mixing it with a solution of radioactive technetium (99mTc).
The radiolabelled medicine is used for diagnostic purposes. NeoSpect is used for patients with solitary pulmonary nodule (small roundish lesion of the lung) detected by CT (computerized axial tomography) or chest x-ray to determine if it is malignant (ie if it is cancer).
The medicine can only be obtained with a prescription.
How is NeoSpect used?
NeoSpect should be handled and administered exclusively by specialist personnel experienced in the safe handling of radioactive materials. NeoSpect should be reconstituted in a radiolabelled solution to be administered by intravenous injection (into a vein); the diagnostic image must 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 an analogue of somatostatin. This means that it acts like somatostatin and binds to the same receptors as somatostatin in the body. These receptors are present in large numbers in some types of malignant tumors, such as lung tumors. Once NeoSpect has been radiolabelled, the radioactive element technetium 99m (99mTc) joins the depreotide. Since depreotide binds to receptors, it brings with it the radioactive element that can thus be detected with the use of special diagnostic imaging tools, for example by scintigraphy or SPECT (single photon emission computed tomography). The possible marking of the solitary pulmonary node with NeoSpect indicates probable malignancy. Otherwise, the nodule will probably be benign (not malignant).
What studies have been carried out on NeoSpect?
NeoSpect has been the subject of two main studies involving 258 patients with suspected lung cancer. Patients underwent CT or chest radiographs as well as SPECT with radiolabelled NeoSpect. The outcome of the examination with NeoSpect was compared with the actual diagnosis formulated based on the histological examination of the nodule (microscopic analysis of the nodule tissue removed surgically). The main efficacy parameter 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 for the doctor the diagnosis of malignancy of the nodule.
What is the risk associated with NeoSpect?
The side effects associated with NeoSpect are rare; those relatively more frequent (observed in 1-10 patients in 1000) are headache, nausea, vomiting, diarrhea, abdominal pain, dizziness, redness and fatigue (fatigue).
NeoSpect should not be used in patients who may be hypersensitive (allergic) to depreotide, sodium pertechnetate or to any of the excipients. NeoSpect should not be used in women who are pregnant or breastfeeding.
Why has NeoSpect been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of NeoSpect outweigh the risks for the scintigraphic examination of lung tumors of suspected malignancy after a first detection, in association with CT or chest radiography, in patients with nodules solitary pulmonary, and therefore recommended the granting of the marketing authorization of the product.
More information on NeoSpect:
On 29 November 2000, the European Commission issued a marketing authorization for NeoSpect, valid throughout the European Union. The marketing authorization was renewed on 29 November 2005. The marketing authorization holder is CIS bio international.
The full EPAR for NeoSpect can be found here .
Last update of this summary: 09-2007.
