Pilot Study on the Feasibility of High-energy Collimation With Optimized Geometry on a VERITON™ CZT Camera

ConditionCancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France

About this trial

Functional imaging using scintigraphy plays a major role in the diagnosis and monitoring of many diseases, particularly thanks to its ability to perform whole-body examinations with high contrast. The indications and use of scintigraphy have increased in recent years, particularly in connection with the development of internal vectorized radiotherapy. This therapeutic approach is based on the administration of radiotracers that enable targeted irradiation of tumor cells, whose biodistribution throughout the body can be analyzed and quantified using scintigraphy, particularly with iodine-131 and lutetium-177.

The recent boom in scintigraphy is also linked to the development of new 360° geometry CZT-SPECT cameras, which enable rapid tomographic acquisitions of the entire body with significantly improved image quality compared to conventional cameras. These systems use mobile CZT semiconductor detectors that dynamically scan the anatomical regions of interest.

CZT detectors are combined with a collimation system consisting of tungsten septa, which are essential for the directional filtering of gamma photons. Unlike conventional scintigraphic cameras, where collimators can be changed or adjusted according to the energy of the detected photons, CZT-SPECT 360° cameras generally rely on fixed collimation, which cannot be changed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients with multiple known lesions (≥ 2 metastases or lesions of other types) who, as part of their clinical management, require either (i) a 99mTc-HDP bone scan, or (ii) a post-therapeutic 177Lu-PSMA scan, or (iii) a post-therapeutic 131I scintigraphy.

Person who has undergone a preliminary clinical examination appropriate for clinical research.

Adult subject who has received complete information about the research and has signed the informed consent form.

General condition, WHO ≤ 2, and ability to remain lying down without moving for nearly an hour.

Disqualifiers

Subjects with a contraindication, according to the target examination group, to injection of 99mTc-HDP (Technescan HDP, Curium Pharma), 177Lu-PSMA (Pluvicto®, Novartis), or 131I (131I sodium iodide for therapy, Curium Pharma) .

Subjects covered by Articles L. 1121-5, L. 1121-7, and L1121-8 of the Public Health Code.

Pregnant women, women in labor, or breastfeeding mothers.

Subjects subject to legal protection measures (guardianship, curatorship, judicial protection).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Scintigraphy VERITON

    Device

    Full-body 3D recording on the VERITON™ 400 camera

  • Scintigraphy VERITON with new collimator

    Device

    \- Whole-body 3D recording on the VERITON™ 400 camera equipped with conventional collimators for technetium-99m and lutetium-177.

  • Scintigraphy SYMBIA

    Device

    Whole-body 2D and cervicothoracic 3D recordings using an Anger camera (SYMBIA camera, Siemens Healthineers) for iodine-131 images.

Treatment groups

18 Participants
are divided into 2 treatment groups
Group A: VERITON-CT NewExperimental treatment 1 intervention
Group B: RéférenceActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Feasability of whole-body SPECT/CT imaging with iodine-131 using the optimized collimator

Data analysis obtained with optimized collimator and with conventional collimator

Time frame
1 month
2

Perform quantitative analysis of technetium-99m and lutetium-177 with feasability results

Image sharpness improvment

Time frame
1 month

Secondary outcomes

1

Overall quality of whole-body CZT acquisitions with iodine-131

For iodine-131, the overall quality of images acquired using the CZT-SPECT camera with the new collimator will be described based on an ordinal score for stellar artifacts (absent, present but not interfering, present and interfering), assessed independently by two experienced readers. The frequency and severity of artifacts will be reported, as well as their association with the interpretable or non-interpretable nature of the examinations defined in the primary endpoint. Inter-reader agreement will also be described.

Time frame
1 month
2

Quantify the detectability and contrast of lesions visualized on whole-body CZT imaging with iodine-131.

Sharpness, defined as the maximum slope of the intensity profile at the edge of the lesions and the contrast-to-noise ratio

Time frame
1 month

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: