DosimetryEVADOVE177LuNCT04467567
Dosimetry Using a CZT-camera Following LUTATHERA® Therapy
A study testing Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT) in people with Dosimetry, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The aim of this study is to assess the consistency between a dosimetry protocol using a large field of view CZT-camera and the dosimetry protocol used for recordings acquired with a conventional camera. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dosimetry
- What is being tested?
- Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 27 Nov 2020to 24 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major adult subject
- ECOG ≤ 2
- Subject receiving treatment with Lutathera®
- Subject having given written, free and informed consent
- Affiliation to a social security scheme
Who cannot join
- Contraindication to treatment with Lutathera®
- Subject referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the public health code.
- Pregnant woman, parturient or nursing mother.
- Subject with a legal protection measure (guardianship, curatorship, safeguard of justice).
- Subject unable to express consent.
- Subject deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care under Articles L. 3212-1 and L.3213-1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimization for Clinical Routine of a Dosimetry Protocol Using the Large Field of View VERITON-CT CZT Camera in Patients Treated With LUTATHERA® [177Lu- [DOTA0, Tyr3] -Octreotate
The aim of this study is to assess the consistency between a dosimetry protocol using a large field of view CZT-camera and the dosimetry protocol used for recordings acquired with a conventional camera. Therefore, with the conventional camera, recordings are acquired on the "high energy" peak of lutetium 177 (208 keV) using a medium energy collimator. With the VERITON-CT™ CZT camera, recordings are acquired using the low energy peak of 113 keV. A second objective is to compare results between the dosimetry calculated using 3 measurement points (24h, 96h and 168h) and the dosimetry calculated using 2 measurement points (24h and 168h), obtained from the SYMBIA T conventional camera and the VERITON-CT™camera, respectively.
Read the detailed description
177Lu-DOTATATE has been proven to be an effective therapy for treatment of neuroendocrine tumors. Treatment with [177Lu]-DOTA-TATE consists of 4 cycles, with an infusion of 7.4 GBq (200mCi) every 8 weeks. An imaging protocol to study dosimetry throughout the cycles is essential to determine the average dose absorbed by critical organs and by tumor lesions. The critical organs studied in association with [177Lu]-octreotate treatment are predominantly kidneys and the bone marrow. In this open-label trial, 15 patients undergoing Lutathera® treatment could be enrolled in the study. Patients will have an abdominopelvic SPECT / CT recorded using a conventional Anger camera, followed by a whole-body SPECT / CT recording using a CZT camera. Recordings will be acquired at 24 hours, 96 hours and then at 7 days after the Lutathera® infusion that is administered during one of the 4 treatment cycles. The correlation between the dosimetry results and the appearance of possible grade 3 and 4 side effects will be established.
- Conditions
- Dosimetry
- Being tested
- Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT)Other
SPECT/CT will be performed after Lutathera® treatment (at 24h, 96h and 168h after the infusion of Lutathera®) on the conventional camera and on the VERITON-CT camera
| Study group | Role | What they receive |
|---|---|---|
| patients treated with lutathera | Experimental | Patients undergoing treatment with Lutathera® and who accept to participate in the study, regardless of the cycle of treatment, 1, 2, 3 or 4. Receives: Other: Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of the dosimetry obtained from the 2 cameras
Comparison between dosimetry results obtained from the conventional camera and from the VERITON-CT™ CZT camera.
Measured: 168 hours
Secondary outcomes (2)
Results of the dosimetry obtained from the 2 cameras when utilizing 3 points of measurement and when utilizing 2 points of measurement
Measurement of the average absorbed doses to sensitive organs (bone marrow and kidneys) and to tumor lesions obtained when utilizing 3 measurement points (24h, 96h and 168h) and then obtained when utilizing 2 measurement points (24h and 168h) after the administration of Lutathera®, from both a VERITON-CT™ camera and from a SYMBIA T camera.
Measured: 24 hours, 96 hours, 168 hours
Correlation between the dosimetry results
Average absorbed doses to the kidneys and to the bone marrow versus renal function (creatininaemia, glomerular filtration rate [GFR], blood ionogram), and versus bone marrow activity (blood count).
Measured: 24 hours, 96 hours, 168 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start27 Nov 2020
- Primary completion25 Mar 2021
- Study completion24 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DosimetryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elodie CHEVALIER, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467567
- Sponsor's protocol ID
- 2020-A20200-620
- Acronym
- EVADOVE177Lu
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2020
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zaragori T, Chevalier E, Citerne Q, Roch V, Hossu G, Marie PY, Boursier C, Imbert L. Assessment of [177Lu]Lu-DOTATATE Dosimetry from High-Speed Whole-Body Recordings Provided by a 360 degrees Cadmium-Zinc-Telluride Camera Compared with Results from a Conventional Anger-Camera Protocol. J Nucl Med. 2025 May 1;66(5):771-777. doi: 10.2967/jnumed.124.268910.
PubMed 40113220
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization for Clinical Routine of a Dosimetry Protocol Using the Large Field of View VERITON-CT CZT Camera in Patients Treated With LUTATHERA® [177Lu- [DOTA0, Tyr3] -Octreotate
- ClinicalTrials.gov ID
- NCT04467567
- Acronym / sponsor ID
- EVADOVE177Lu / 2020-A20200-620
- Conditions
- Dosimetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 27 Nov 2020 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 24 Jul 2023 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess the consistency between a dosimetry protocol using a large field of view CZT-camera and the dosimetry protocol used for recordings acquired with a conventional camera. Therefore, with the conventional camera, recordings are acquired on the "high energy" peak of lutetium 177 (208 keV) using a medium energy collimator. With the VERITON-CT™ CZT camera, recordings are acquired using the low energy peak of 113 keV. A second objective is to compare results between the dosimetry calculated using 3 measurement points (24h, 96h and 168h) and the dosimetry calculated using 2 measurement points (24h and 168h), obtained from the SYMBIA T conventional camera and the VERITON-CT™camera, respectively.
Detailed description
177Lu-DOTATATE has been proven to be an effective therapy for treatment of neuroendocrine tumors. Treatment with [177Lu]-DOTA-TATE consists of 4 cycles, with an infusion of 7.4 GBq (200mCi) every 8 weeks. An imaging protocol to study dosimetry throughout the cycles is essential to determine the average dose absorbed by critical organs and by tumor lesions. The critical organs studied in association with [177Lu]-octreotate treatment are predominantly kidneys and the bone marrow. In this open-label trial, 15 patients undergoing Lutathera® treatment could be enrolled in the study. Patients will have an abdominopelvic SPECT / CT recorded using a conventional Anger camera, followed by a whole-body SPECT / CT recording using a CZT camera. Recordings will be acquired at 24 hours, 96 hours and then at 7 days after the Lutathera® infusion that is administered during one of the 4 treatment cycles. The correlation between the dosimetry results and the appearance of possible grade 3 and 4 side effects will be established.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients treated with lutathera | Experimental | Other: Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT)Patients undergoing treatment with Lutathera® and who accept to participate in the study, regardless of the cycle of treatment, 1, 2, 3 or 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Major adult subject
- ECOG ≤ 2
- Subject receiving treatment with Lutathera®
- Subject having given written, free and informed consent
- Affiliation to a social security scheme
Key exclusion criteria (6 listed)
- Contraindication to treatment with Lutathera®
- Subject referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the public health code.
- Pregnant woman, parturient or nursing mother.
- Subject with a legal protection measure (guardianship, curatorship, safeguard of justice).
- Subject unable to express consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT)SPECT/CT will be performed after Lutathera® treatment (at 24h, 96h and 168h after the infusion of Lutathera®) on the conventional camera and on the VERITON-CT camera | Other | patients treated with lutathera |
Primary outcome
Results of the dosimetry obtained from the 2 cameras
Time frame: 168 hours
Comparison between dosimetry results obtained from the conventional camera and from the VERITON-CT™ CZT camera.
2 secondary outcomes
Results of the dosimetry obtained from the 2 cameras when utilizing 3 points of measurement and when utilizing 2 points of measurement
Time frame: 24 hours, 96 hours, 168 hours
Correlation between the dosimetry results
Time frame: 24 hours, 96 hours, 168 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Results publication: PubMed 40113220Zaragori T, Chevalier E, Citerne Q, Roch V, Hossu G, Marie PY, Boursier C, Imbert L. Assessment of [177Lu]Lu-DOTATATE Dosimetry from High-Speed Whole-Body Recordings Provided by a 360 degrees Cadmium-Zinc-Telluride Camera Compared with Results from a Conventional Anger-Camera Protocol. J Nucl Med. 2025 May 1;66(5):771-777. doi: 10.2967/jnumed.124.268910.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT) in people with Dosimetry, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Results of the dosimetry obtained from the 2 cameras (time frame: 168 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04467567, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.