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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07572318
Acronym
HELIOS
Enrollment
18
Registered
2026-05-07
Start date
2026-05-01
Completion date
2027-05-01
Last updated
2026-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

scintigraphy, scintigraphy post therapeutic

Brief summary

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.

Detailed description

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.

Interventions

DEVICEScintigraphy VERITON

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

DEVICEScintigraphy VERITON with new collimator

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

DEVICEScintigraphy SYMBIA

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

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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). * Subjects unable to give their consent. * Subjects deprived of their liberty by a judicial or administrative decision, persons receiving psychiatric care pursuant to Articles L. 3212-1 and L.3213-1.

Design outcomes

Primary

MeasureTime frameDescription
Feasability of whole-body SPECT/CT imaging with iodine-131 using the optimized collimator1 monthData analysis obtained with optimized collimator and with conventional collimator
Perform quantitative analysis of technetium-99m and lutetium-177 with feasability results1 monthImage sharpness improvment

Secondary

MeasureTime frameDescription
Overall quality of whole-body CZT acquisitions with iodine-1311 monthFor 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.
Quantify the detectability and contrast of lesions visualized on whole-body CZT imaging with iodine-131.1 monthSharpness, defined as the maximum slope of the intensity profile at the edge of the lesions and the contrast-to-noise ratio

Contacts

CONTACTAnne-Sophie Hue Project Manager, MSc
a.hue@chru-nancy.fr+33.3.83.15.34.75

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 8, 2026