Pixclara

Pixclara (floretyrosine F 18) is a radioactive dye used in a PET scan to help doctors tell the difference between a glioma (a type of brain tumor) that is growing back and changes caused by cancer treatment. It is given as a single injection into a vein before the scan. It is not a cancer treatment.

Pixclara is used in people who have already been treated for glioma, a type of brain tumor. After surgery, radiation, or chemotherapy, a spot on an MRI scan can look like a tumor when it is actually scar tissue or swelling caused by the treatment itself. Pixclara is designed to help sort out which one it is.

Pixclara was approved by the FDA on September 14, 2026. It is made by Telix Pharmaceuticals and is given to adults and to children from 1 month of age.

Pixclara is FDA-approved for use with positron emission tomography (PET) to tell the difference between glioma that has come back or is getting worse and changes caused by treatment.

The Pixclara scan is used alongside other tests, not instead of them. Your doctor will look at the scan result together with your MRI scans, your symptoms, your medical history and, in some cases, a tissue sample (biopsy).

Do guidelines recommend this type of scan?

Yes, although the guidance covers this type of scan rather than this particular product. Pixclara belongs to a group of scans called amino acid PET.

The Response Assessment in Neuro-Oncology (RANO) working group and the European Association of Neuro-Oncology updated their recommendations on PET imaging in glioma in 2025. Telling a returning tumor apart from treatment-related change is one of the main reasons they give for using this kind of scan.

These recommendations are written for specialists and do not name Pixclara, which was only approved in September 2026. If you think this kind of scan might help in your situation, the person to ask is the doctor managing your brain tumor care.

What is a glioma?

A glioma is a tumor that starts in the glial cells, which are the supporting cells of the brain and spinal cord. Gliomas range from slow-growing to fast-growing, and doctors describe them by grade, from grade 1 to grade 4. Glioblastoma is a grade 4 glioma.

After treatment, gliomas are checked with regular MRI scans. The problem is that radiation and some cancer medicines can leave behind swelling, scarring, and damaged tissue that shows up on an MRI in a way that looks very similar to a returning tumor. Doctors call this a treatment-related change, and it includes pseudoprogression and radiation necrosis.

Pixclara works by using a building block of protein to find active tumor cells. Floretyrosine is a man-made version of tyrosine, one of the amino acids the body uses to make protein. It is joined to a small amount of a radioactive tracer called fluorine-18.

Tumor cells take in amino acids through doorways on their surface called LAT1 and LAT2 transporters. Glioma cells have many more of these doorways than normal brain tissue does, so they pull in more of the tracer. The PET scanner picks up the signal given off by the fluorine-18 and shows the areas of higher uptake as bright spots on the image.

Scar tissue and treatment-related swelling do not take up the tracer in the same way, which is what allows the scan to help tell the two apart.

Pixclara was tested in two studies of people who had already been treated for glioma and whose MRI scans suggested the tumor might be growing again. In these studies the scan correctly identified returning tumor in 66% to 83% of people who had one, depending on the study and the doctor reading the scan.

In both studies, three nuclear medicine specialists read the Pixclara scans without knowing anything else about the patient. Their readings were then compared with a reference standard worked out by a panel of experts who reviewed MRI scans, biopsy reports, surgical reports and clinical notes.

Study 1

Study 1 (NCT04044937) included 127 people, made up of 116 adults and 11 children and teenagers aged 5 to 16 years. About half had recurrent or progressive glioma according to the reference standard.

• Positive results: the scan was positive in 70% to 83% of people who did have returning or growing tumor.
• Negative results: the scan was negative in 48% to 64% of people who did not.

Study 2

Study 2 looked back at 254 people scanned during everyday clinical practice at several centers. This group was made up of 253 adults and one 16 year old. Again, about half had recurrent or progressive glioma.

• Positive results: the scan was positive in 66% to 72% of people who did have returning or growing tumor.
• Negative results: the scan was negative in 53% to 61% of people who did not.

What these numbers mean

Pixclara improves on what an MRI alone can tell you, but it does not give a yes or no answer. The results above show that the scan misses some tumors and also flags some areas that turn out not to be tumor. This is why the FDA label states that a negative scan does not rule out returning glioma and a positive scan does not confirm it, and why the result is always read alongside your other tests.

No. An MRI shows the structure of the brain, meaning the shape, size and position of anything unusual. A Pixclara PET scan shows activity, meaning how much of the tracer an area is taking in. The two tests answer different questions, and a Pixclara scan is used in addition to MRI rather than in place of it.

In practice, many people have a PET scan and an MRI or CT scan at the same visit, because the pictures are lined up on top of each other to show exactly where the active areas sit in the brain.

The scan result can be wrong

A Pixclara scan can give a false positive or a false negative result. A negative scan does not rule out glioma that is coming back or getting worse, and a positive scan does not confirm it. Some scans give an unclear result, such as low-level or unusual patterns of uptake.

Things that can make a scan look positive when there is no tumor include:

• Inflammation or infection in the brain
• Some of the tracer still sitting in the blood at the time of the scan, which can brighten large blood vessels
• Abnormal tangles of blood vessels, such as arteriovenous malformations, angiomas and cavernomas

Things that can make a scan look negative when there is a tumor include:

• Tumors that take up the tracer unevenly, so part of the tumor looks normal
• Small tumors, which can be hard for the scanner to measure accurately
• Natural differences in background brain uptake, for example in people whose brain tissue has thinned with age (atrophy)

This is why your doctor reads the scan alongside your MRI scans, your history and, where available, biopsy results.

Radiation risks

Pixclara adds to the total amount of radiation you are exposed to over your lifetime, and higher lifetime radiation exposure is linked to a higher risk of cancer. A dose of 259 MBq, the largest adult dose, gives an effective radiation dose of about 4.1 millisieverts (mSv). If a CT scan is used at the same time to line up the images, that adds more radiation on top.

The bladder receives the highest dose of any organ, because the tracer leaves the body in urine. To lower your exposure:

• Drink water before and after your scan
• Empty your bladder just before the scan if you can
• Empty your bladder often for the rest of the day

There are no contraindications for Pixclara, which means the label does not list any condition that rules it out. Even so, tell the healthcare team before your scan if you:

• Are pregnant or think you could be pregnant
• Are breastfeeding
• Have had any other scan using a radioactive tracer recently
• Have any trouble lying still or lying flat for about 20 minutes

Tell them about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins and herbal products.

Pregnancy

There is no information on the use of floretyrosine F 18 in pregnancy. All radioactive tracers, including Pixclara, can potentially harm an unborn baby, depending on the stage of the pregnancy and the amount of radiation. If you are pregnant, your doctor should talk through the possible risks with you before the scan.

Breastfeeding

If you are breastfeeding, stop temporarily and pump and throw away your breast milk for at least 4 hours after your Pixclara injection. There is no information on whether floretyrosine F 18 passes into breast milk, and this waiting time is a precaution to limit the baby's radiation exposure.

You need to fast for at least 4 hours before your Pixclara injection. Water is not only allowed during this time, it is encouraged.

• Do not eat for at least 4 hours before the injection.
• Drink water during the fasting period and after the injection.
• Empty your bladder just before the scan starts if you can.
• Empty your bladder often after the scan.

A Pixclara PET scan takes about an hour from injection to the end of the scan. The injection itself takes seconds, then there is a wait while the tracer travels to the brain, then the scan.

• Pixclara is injected quickly into a vein, followed by a flush of saline (salt water) to make sure the full dose goes in.
• You wait 20 to 30 minutes.
• You lie on the scanner bed with your head resting in a padded holder and your arms by your sides. Soft padding or tape may be used to keep your head still.
• The scan runs for 20 minutes. Only your head is scanned.
• A low dose CT or MRI scan may be done at the same visit so the pictures can be lined up.

Staff who handle Pixclara wear gloves and use shielding, because they work with radioactive tracers every day. This is a workplace safety measure and is not a sign that the dose you receive is unsafe.

Side effects from Pixclara are uncommon. In studies of 382 people, the only side effect reported by 0.5% or more of people was headache.

Common Pixclara side effects

• Headache, reported by 0.5% of people

Side effects reported by fewer than 0.5% of people were:

• Nausea
• A reaction where the needle went in, such as redness or soreness
• Tiredness
• A general feeling of being unwell (malaise)

Children and teenagers in the studies had the same pattern of side effects as adults.

Serious side effects

No serious side effects were linked to Pixclara in the clinical studies, and the label lists no contraindications, meaning there is no group of people who must not have it.

The main safety issues with Pixclara are not side effects in the usual sense. They are the radiation the tracer carries, and the chance that the scan image is read incorrectly. Both are covered in the warnings section below.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual adult dose of Pixclara for glioma imaging

• Dose: 185 MBq to 259 MBq (5 mCi to 7 mCi) given as a quick injection into a vein.
• Given once, as a single dose, before the PET scan.
• Imaging starts 20 to 30 minutes after the injection and runs for 20 minutes.

Usual dose of Pixclara for children 1 month of age and older

• Dose: 3 MBq per kilogram of body weight (0.081 mCi/kg) given as a quick injection into a vein.
• The smallest dose used is 14 MBq (0.38 mCi) and the largest is 259 MBq (7 mCi).
• Pixclara has not been studied in babies under 1 month of age.

Pixclara is always prepared and given by trained healthcare staff who are licensed to handle radioactive medicines. There is no dose for you to measure or take at home.

Dosing in older adults

No dose change is needed based on age. In the clinical studies, 180 people (28.3%) were 65 or older and 51 people (8.0%) were 75 or older. Safety and results were no different in this group.

Call the imaging center to rebook as soon as you can. Pixclara is a single dose given at the time of your scan, so there is no missed dose to make up and nothing to take at home. The dose has to be made close to the time of your appointment because the radioactive tracer fades quickly, so let the center know as early as possible if you cannot make it.

Pixclara is measured and given by trained staff, so an overdose is unlikely. If too much is given, the team will encourage you to drink fluids and empty your bladder often to clear the tracer from your body faster. A water tablet (diuretic) may also be used.

No drug interactions have been identified with Pixclara. In laboratory testing, floretyrosine did not affect the CYP liver enzymes CYP1A2, CYP2B6 or CYP3A4, and it did not interact with the P-gp, BCRP or BSEP transporter systems that move many medicines around the body.

Because Pixclara is a single, very small dose given once, interactions with your regular medicines are not expected. Still, tell the healthcare team about everything you take, including prescription and over-the-counter medicines, vitamins, and herbal products, so they have the full picture when they read your scan.

Healthcare professionals and patients often use the Pixclara Package Insert (PI) for more detailed information about this medicine. The Package Insert covers Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, and more. It is sometimes called the Prescribing Information or the FDA label.

The Package Insert does not contain everything you need to know for safe and effective use, and it does not take the place of talking to your doctor about your scan and your results.

Pixclara is supplied to imaging centers as a clear, colorless to slightly yellow solution in a shielded multiple-dose glass vial holding about 15 mL (NDC 74725-338-30). It is stored upright at 15°C to 25°C (59°F to 77°F) in its original shielded container.

Pixclara must be used within 14 hours of being made. It is handled only by staff licensed by the Nuclear Regulatory Commission or the equivalent state authority, and it is never dispensed to patients.

Active ingredient: floretyrosine F 18

Inactive ingredients: sodium ascorbate and 0.9% sodium chloride injection

Pixclara is manufactured for Telix Pharmaceuticals US, Inc., 11700 Exit 5 Pkwy, Suite 200, Fishers, IN 46037, USA.