Precision medicine is a major goal in oncology. It aims to tailor treatments to the specific characteristics of each patient's tumor. This approach makes it possible to identify unique therapeutic targets and select the therapeutic alternative that specifically targets the abnormalities identified. Positron emission tomography (PET) plays a key role in this approach by providing detailed functional imaging of tumors in a non-invasive way. Usually, one radio-tracer is used to perform PET. Depending on the type of tumor, each tracer is carefully selected for its specific behavior and characteristics. However, it may be useful to perform several PET scans with different tracers, each providing different information, for the initial staging and therapeutic management of patients. Hepatocellular carcinoma (HCC), the most common form of liver cancer and the third leading cause of cancer-related death, requires precise imaging for optimal treatment selection. \[18F\]F-choline PET is often preferred for the initial detection of well-differentiated HCC and local recurrence, while \[18F\]FDG (fluorodésoxyglucose) PET is more useful for aggressive forms of HCC and for assessing metastases. Similarly, gastro-entero-pancreatic tumors (GEP-NETs), a type of neuroendocrine tumor found in the gastrointestinal tract and pancreas, also benefit from tailored imaging approaches. GEP-NETs commonly express somatostatin receptors, which are effectively targeted by \[68Ga\]Ga-DOTATOC PET to enhance diagnostic accuracy and staging, particularly in well-differentiated lesions. Conversely, \[18F\]FDG PET is valuable for imaging GEP-NETs with high metabolic activity, providing insight into tumor aggressiveness and proliferation. The combined use of \[18F\]FDG PET and \[18F\]F-choline PET in HCC, as well as \[68Ga\]Ga-DOTATOC PET and \[18F\]FDG PET in GEP-NETs, provides complementary information that helps to comprehensively characterize the tumor, guide treatment decisions, and monitor therapeutic response. In this context, a highly innovative way using multiplexed PET imaging offers potential for targeted therapy and precision medicine. The aim of this study is to evaluate the use of simultaneous dual-tracer PET imaging with a staggered injection (referred to here as multiplexed PET), combining \[18F\]FDG and \[18F\]F-choline in HCC, and \[68Ga\]Ga-DOTATOC and \[18F\]FDG in GEP-NETs as compared to both pairs of single PET.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
28
Single tracer PET/CT for the HCC patients : one with \[18F\]FDG and one with \[18F\]F-choline Single tracer PET/CT for the GEP-NET patients : one with \[68Ga\]Ga-DOTATOC and one with \[18F\]FDG
Multiplexed PET-CT for HCC patients : \[18F\]FDG + \[18F\]F-choline. Multiplexed PET-CT for GEP-NET patients : \[18F\]FDG + \[68Ga\]Ga-DOTATOC. The PET scans must be performed in any order and at least 24 hours apart.
CHU Brest
Brest, France
NOT_YET_RECRUITINGHopital Foch (AP-HP)
Clichy, France
NOT_YET_RECRUITINGChu Nantes
Nantes, France
RECRUITINGAdverse reactions collection
Safety of the staggered injection of two radiopharmaceuticals via a single route of administration will be monitored after multiplexed radiopharmaceuticals administration and until 30 minutes after the end of the image acquisition. Adverse reactions (ARs) will be collected during that period of time.
Time frame: until 30 minutes after first injection of the first radiophamaceutical
Technical Feasibility of the imaging reconstruction
Technical feasibility will be qualitatively assessed for each patient by the scientific committee at the time of reconstruction of each multiplex acquisition. An image free from artifacts interfering with visual interpretation will be considered as suitable for diagnostic evaluation.
Time frame: within 12 months
Number of positive lesions
Evaluation of the diagnostic efficacy of multiplexed PET imaging for the detection and staging of both types of tumors compared to single-radiopharmaceutical PET imaging. It will be assessed by the number positive lesions using the multiplexed approach compared to lesions detected with both single-tracer PET scans. The sensitivity of the multiplex imaging over both single-tracer PET will be calculated.
Time frame: within 12 months
Location of positive lesions
Evaluation of the diagnostic efficacy of multiplexed PET imaging for the detection and staging of both types of tumors compared to single-radiopharmaceutical PET imaging. It will be assessed by the location of positive lesions using the multiplexed approach compared to lesions detected with both single-tracer PET scans. The sensitivity of the multiplex imaging over both single-tracer PET will be calculated.
Time frame: within 12 months
quantitative information of positive lesions
Evaluation of the diagnostic efficacy of multiplexed PET imaging for the detection and staging of both types of tumors compared to single-radiopharmaceutical PET imaging. It will be assessed by the quantitative information of positive lesions using the multiplexed approach compared to lesions detected with both single-tracer PET scans. The sensitivity of the multiplex imaging over both single-tracer PET will be calculated.
Time frame: within 12 months
Visual quality of multiplexed image for clinical use
A global assessment will be given for each multiplex imaging for the use in clinical practice. This assessment will then be summarised and presented by basket. The following scoring system will be used: * Noise quantification : 0. No noise / 1. Moderately increased noise / 2 Highly increased noise * Artifact detection: 0. No artifact/ 1. Presence of non-invasive artifact / 2. Presence of invasive artifact A score of 3 or more indicates poor imaging quality.
Time frame: within 30 days after the first PET scan
patients' satisfaction
Acceptability will be assessed using an ordinal scale from 1 (very uncomfortable) to 5 (very comfortable) and a one-question survey asking participants to indicate their preference between undergoing two separate single-tracer PET scans or one multiplexed PET scan
Time frame: within 30 days after the first PET scan
Ki computation on each of dynamic image acquisitions
Exploratory analysis for patients who agreed to have dynamic whole body acquisition : Ki (capture kinetics min-1) computation on each of dynamic image acquisitions
Time frame: within 12 months
Tumor normalized uptake values (SUV) (Exploratory analysis)
Exploratory analysis for patients who agreed to have dynamic whole body acquisition : Tumor normalized uptake values (SUV) will be determined on each imaging PET to evaluate whether dynamic PET/CT (computing tomography) imaging (including multiplexed imaging) improves lesion detection compared with static PET/CT
Time frame: within 12 months
Vd computation on each of dynamic image acquisitions
Exploratory analysis for patients who agreed to have dynamic whole body acquisition : Vd (volume of distribution) computation on each of dynamic image acquisitions
Time frame: within 12 months
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