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NCT Number: NCT07572318

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 1 month

    Data analysis obtained with optimized collimator and with conventional collimator

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

    Time frame: 1 month

    Image sharpness improvment

Secondary outcomes

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

    Time frame: 1 month

    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.

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

    Time frame: 1 month

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

Study contacts

Contact information is provided by the study sponsor or research team.

Anne-Sophie Hue Project Manager, MSc

CONTACT

[email protected]

+33.3.83.15.34.75

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: HELIOS

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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