Unleash the Power of Lightning with AI

Illuccix plus SubtlePET™ for enhanced clinical workflow

AI-powered Illuccix imaging: faster scans, optimized workflow, and enhanced patient experience

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Workflow efficiency and capacity


Increased throughput allows for more 
scans within the same time frame with
no additional effort

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Imaging flexibility

Works with any brand of scanner. Allows for quality images even if patients are delayed and activity is lower

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Patient experience


Less time spent in bed

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Scanner lifetime extension

By improving accelerated image quality, SubtlePET may extend the lifetime of older scanners

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SubtlePET allows faster scanning without sacrificing image quality

SubtlePET is an FDA-cleared AI-powered software that reconstructs images to allow for up to 75% faster scans

Infographic of a PET scan using current scan protocol taking 18 minutes and an accelerated scan with SubtlePET taking 4.5 minutes
Infographic of a PET scan using current scan protocol taking 18 minutes and an accelerated scan with SubtlePET taking 4.5 minutes

GE Discovery MI (68Ga-PSMA)

Original scan

Original scan

Acq Time: 28 min

Illuccix scan accelerated and enhanced by SubtlePET

Scan accelerated and enhanced by SubtlePET™

Acq Time: 7 min

Maintains high image quality with reduced processing time.

Representative case study of a 68Ga-PSMA-11 PET/CT scan. Image results may vary.

Easy implementation without workflow changes or disruptions

Installation with both cloud and on-premise support

Compatible with ANY brand of scanner, PACS or OEM

Scans take seconds to process, with <5 minutes total transfer time (depending on internal bandwidth)

Patient scans are completely anonymized before being processed by SubtlePET

Infographic showing images from any scanner are sent to SubtlePET which enhances the images and sends them back to PACS/workstations to be read
Infographic showing images from any scanner are sent to SubtlePET which enhances the images and sends them back to PACS/workstations to be read

Images are sent from any scanner and are processed by SubtlePET within seconds. The high-quality images are then sent to PACS and/or other workstations for reading.

Faster scans with equivalent accuracy

Scans enhanced by SubtlePET provided a 75% time savings with the same image quality 

GE Discovery MI (68Ga-PSMA)

Original scan

Original scan

Acq Time: 28 min

Illuccix scan accelerated and 
enhanced by SubtlePET

Scan accelerated and enhanced by SubtlePET™

Acq Time: 7 min

GE Discovery MI (68Ga-PSMA)

Original scan

Original scan

Acq Time: 28 min

Illuccix scan accelerated and 
enhanced by SubtlePET

Scan accelerated and enhanced by SubtlePET™

Acq Time: 7 min

Representative case study of a 68Ga-PSMA-11 PET/CT scan. Image results and time savings may vary.

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Measurable impact on treatment planning and patient experience

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“Decreasing the time between the CT scan for attenuation correction and the final bed positions reduces motion artifacts significantly and enables better scan quality. Both patient motion and filling of internal fluids and organs are reduced. As a result, the quality of read for the radiologist and the quality for treatment planning with the oncologist is improved.

– Darren M., 

Precision Imaging Centers  

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“I have severe back pain and couldn’t hold still during scans. Today, for the first time, I was comfortable during my 6-minute scan.

– Patient 

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“This is amazing. Very pleasant and short scan compared to my previous scan.” 

– Patient 

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“Patients have gone out of their way to share with us how much they enjoy the shorter scan times, especially our patients who have to undergo regularly scheduled PET exams. For being such a quick and easy implementation, SubtlePET has had a huge impact on our patients and our operations.

– Physician 

Quantitative accuracy (SUV max) of accelerated scans with SubtlePET was equivalent to standard-duration protocols

Lesions SUV Max Variations

Line graph of the number of lesions SUV max variations between standard duration scans and accelerated SubtlePET-enhanced scans
Line graph of the number of lesions SUV max variations between standard duration scans and accelerated SubtlePET-enhanced scans

Quantitative Accuracy

Lesions_max

Original scan

0.990209

mann_whitney_u

0.789741

pearson

0.991324

rmse_cv

5.686397

Concordance coefficient: 0.99

SUV=standardized uptake volume 

Ref: Quantitative Standardized Uptake Value Evaluation of 4x Faster PET Scans Enhanced using Deep Learning, A Chaudhari, PhD, RSNA

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Indications and Usage

ILLUCCIX, after radiolabeling with Ga-68, is 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

WARNINGS AND PRECAUTIONS

Risk for Misinterpretation
Image interpretation errors can occur with ILLUCCIX PET. A negative image does not rule out the presence of prostate cancer, and a positive image 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 non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Indications and Usage

ILLUCCIX, after radiolabeling with Ga-68, is 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

WARNINGS AND PRECAUTIONS

Risk for Misinterpretation
Image interpretation errors can occur with ILLUCCIX PET. A negative image does not rule out the presence of prostate cancer, and a positive image 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 non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. 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 ILLUCCIX for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of ILLUCCIX for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score.

Imaging to Select Patients for Lutetium Lu 177 Vipivotide Tetraxetan Therapy
The interpretation of ILLUCCIX PET may differ depending on imaging readers. ILLUCCIX 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 one tumor lesion compared to judging uptake for all lesions larger than size criteria. Multidisciplinary consultation to select patients for lutetium Lu 177 vipivotide tetraxetan therapy is recommended, particularly for ILLUCCIX 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 Risks
Gallium Ga-68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration.

ADVERSE REACTIONS

The safety of gallium Ga-68 gozetotide was evaluated in 960 patients in the PSMA-PreRP and PSMA-BCR studies, each receiving one dose of gallium Ga-68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%.

In the VISION study, 1003 patients received one dose of gallium Ga-68 gozetotide intravenously with the amount of radioactivity 167.1 ± 23.1 MBq (4.52 ± 0.62 mCi). Adverse reactions occurring at ≥0.5% in patients with metastatic prostate cancer who received gallium Ga-68 gozetotide injection in the clinical study were fatigue (1.2%), nausea (0.8%), constipation (0.5%), and vomiting (0.5%).

Adverse reactions occurring at a rate of < 0.5% in the VISION study were diarrhea, dry mouth, injection site reactions, including injection site hematoma and injection site warmth and chills.

DRUG INTERACTIONS

Androgen deprivation therapy and other therapies targeting the androgen pathway

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga-68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga-68 gozetotide PET has not been established.

Please note that this information is not comprehensive.

Please see  the Full Prescribing Information.

You are encouraged to report suspected adverse reactions of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report adverse reactions to Telix Pharmaceuticals (US) by calling 1-844-455-8638 or emailing pharmacovigilance@telixpharma.com.