Risk for Misinterpretation
Image interpretation errors can occur with LOCAMETZ PET. Negative imaging does not rule out the presence of prostate cancer and a positive imaging does not confirm the presence of prostate cancer. ...
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Locate a LOCAMETZ Scanning Center Near You
LOCAMETZ® (kit for the preparation of gallium Ga 68 gozetotide injection) is available at select scanning centers across the United States. See below to find the LOCAMETZ scanning center nearest to you. Click on each search result listing for more information, including address, telephone number, and website. Please note that the LOCAMETZ scanning centers listed here are only those that have authorized their inclusion on our website. Please check back regularly, as this list will be updated with newly certified locations.
Scanning centers may have different patient eligibility criteria. Please contact the scanning center directly for more information.
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Advanced Accelerator Applications, a Novartis Company, does not provide or supervise medical care furnished through these scanning centers, which are independently owned and operated.
Indication
LOCAMETZ® (kit for the preparation of gallium Ga 68 gozetotide injection), after radiolabeling with gallium-68, is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer:
- with suspected metastasis who are candidates for initial definitive therapy
- with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
- for selection of patients with metastatic prostate cancer for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated
IMPORTANT SAFETY INFORMATION
Risk for Misinterpretation
Image interpretation errors can occur with LOCAMETZ PET. Negative imaging does not rule out the presence of prostate cancer and a positive imaging does not confirm the presence of prostate cancer. Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as nonmalignant processes. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.
Imaging prior to initial definitive or suspected recurrence therapy
The performance of LOCAMETZ seems to be affected by serum PSA levels and by site of disease for imaging of biochemically recurrent prostate cancer, and by Gleason score for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy.
Imaging to select patients for lutetium Lu 177 vipivotide tetraxetan therapy
The interpretation of LOCAMETZ PET may differ depending on imaging readers. LOCAMETZ PET interpretations to select patients for lutetium Lu 177 vipivotide tetraxetan therapy may be more consistent when judging gallium Ga 68 gozetotide uptake in any 1 tumor lesion compared with judging uptake for all lesions larger than size criteria. Multidisciplinary consultation is recommended, particularly for LOCAMETZ imaging that a single reader finds borderline or difficult to interpret, or when patient eligibility hinges only on judgment of gallium Ga 68 gozetotide uptake for all lesions larger than size criteria.
Radiation Risk
Gallium Ga 68 gozetotide contributes to a patient’s long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Ensure safe handling to minimize radiation exposure to the patient and health care workers. Advise patients to be well hydrated prior to gallium Ga 68 gozetotide administration and to void immediately prior to and frequently during the first hours after image acquisition to reduce radiation exposure.
Adverse Reactions
Adverse reactions ≥0.5% in the VISION study were fatigue (1.2%), nausea (0.8%), constipation (0.5%), and vomiting (0.5%). Adverse reactions occurring at a rate of <0.5% were diarrhea, dry mouth, injection site reactions, and chills.
Please see full Prescribing Information.
