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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer
• Intervention / Treatment: Device: Scintigraphy VERITON with new collimator; Device: Scintigraphy VERITON; Device: Scintigraphy SYMBIA

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.

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne-Sophie Hue Project Manager, MSc; Phone Number: +33.3.83.15.34.75; Email: a.hue@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VERITON-CT New; Optimized collimators for the CZT detectors of the VERITON™ 400 wide-field camera (Spectrum Dynamics Medical) enabling better selection of incident photons	Device: Scintigraphy VERITON with new collimator; - Whole-body 3D recording on the VERITON™ 400 camera equipped with conventional collimators for technetium-99m and lutetium-177.
Active Comparator: Référence; Full-body 3D recording on the VERITON™ 400 camera equipped with conventional collimators for technetium-99m and lutetium-177.; 2D whole-body and 3D cervicothoracic recordings on an Anger camera (SYMBIA camera, Siemens Healthineers) for iodine-131 images.	Device: Scintigraphy VERITON; Full-body 3D recording on the VERITON™ 400 camera; Device: Scintigraphy SYMBIA; Whole-body 2D and cervicothoracic 3D recordings using an Anger camera (SYMBIA camera, Siemens Healthineers) for iodine-131 images.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasability of whole-body SPECT/CT imaging with iodine-131 using the optimized collimator	Data analysis obtained with optimized collimator and with conventional collimator	1 month
Perform quantitative analysis of technetium-99m and lutetium-177 with feasability results	Image sharpness improvment	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month
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	1 month

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: scintigraphy; scintigraphy post therapeutic
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2026-A00456-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No