Neuroendocrine TumorsGAPET-NETNCT03576040
Whole Body Dynamic 68Ga-DOTATOC PET/CT in Neuroendocrine Tumors
An observational study of Neuroendocrine Tumors, run by University Hospital, Brest at 1 site in France.
Trial summary
Neuroendocrine tumors (NET) are a network of rare tumors with common embryological origin. Functional imaging plays a major role in the extension assessment and tumor characterization of NETs. SPECT/CT with 111In-pentetreotide is the recommended test when tumors are well differentiated (grade G1 or G2). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- Whole Body Dynamic 68Ga-DOTATOC PET/CT
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jul 2018to 6 Jul 2023
- Phase
- Observational
- 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 to 100 years
- All sexes
- Adult, Older adult
Study population: Patients with NET histologically proven and presented in RCP RENATEN at CHRU Brest Primitive: Gastroenteropancreatic, bronchopulmonary or unknown
Who may be able to join
- Patient majeur ≥ 18 year old
- Présenting a well differentiated neuroendocrine tumor (G1 ou G2)
- Indication performing a68Ga-DOTATOC PET/CT
- non-opposition
Who cannot join
- Patient <18 years old
- Breastfeeding/ pregnancy
- Other type of tumor
- Refusal of participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Interest of a Whole Body Dynamic PET Acquisition in Pre-therapeutic 68Ga-DOTATOC PET/CT for Neuroendocrine Tumors
Neuroendocrine tumors (NET) are a network of rare tumors with common embryological origin. Functional imaging plays a major role in the extension assessment and tumor characterization of NETs. SPECT/CT with 111In-pentetreotide is the recommended test when tumors are well differentiated (grade G1 or G2). It has a real interest in diagnosis, in therapeutic decision-making (in particular by cold somatostatin analogues or in PRRT) and in the systematic follow-up of patients. Nevertheless, SPECT/CT procedure makes for a relatively long review. In addition, scintigraphy has a lower spatial resolution than PET technology and remains of limited interest for signal quantification.
However, the ability to locate and quantitatively measure the absorption of radiopharmaceuticals in the target tissues is a major challenge in oncology for the characterization of the disease.
Read more
Recent developments in radiopharmacy have made it possible to target NETs in PET imaging through the use of somatostatin analogues coupled with positron emitters, called 68Ga-DOTA peptides. The diagnostic performance of 68Ga-DOTApeptide PET/CT appears to be superior to SPECT/CT with 111In-pentetreotide. A marketing authorization has thus recently been issued in France for the use of 68Ga-DOTATOC.
Historically, the recommended quantification method in PET was based on the instantaneous measurement in static acquisition (3D) of the maximum of the standardized uptake value (SUVmax). This approach has the disadvantage to measure the signal at a time "t" for a single voxel of the image. Dynamic acquisition methods (4D) have been proposed to extract a radiotracer absorption coefficient (Ki) for a lesion. Several studies have demonstrated the superiority of Ki versus SUVmax in 18FDG PET/CT for the diagnostic management, therapeutic evaluation and prognosis of various solid cancers.
However, no work has validated this approach in PET / CT at 68Ga-DOTATOC as part of the prognostic evaluation of NETs.
The objective of the study is to evaluate the prognostic value of the tumor absorption coefficient Ki resulting from a 4D whole-body dynamic acquisition in PET / CT at 68Ga-DOTATOC in patients with well-differentiated NETs grade I or II according to the WHO classification
- Conditions
- Neuroendocrine Tumors
- Being tested
- Whole Body Dynamic 68Ga-DOTATOC PET/CT
- Keywords
- Positron Emission Tomography Computed Tomography, whole body dynamic acquisition, Gallium 68
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Body Dynamic 68Ga-DOTATOC PET/CTDevice
68Ga-DOTATOC PET-CT will be performed in the nuclear medicine department of the University Hospital of Brest on a Biograph mCT S64 machine (Siemens medical, Erlangen, Germany) "Time of Flight" system after intravenous injection of 150MBq of 68Ga-DOTATOC. In the usual conditions for performing this exam, the patient must remain at a strict rest for 60 minutes following the injection of the tracer and before a static 3D acquisition. For this protocol, a complementary 4D dynamic acquisition (15-60 minutes post-injection) will be performed during this usual rest period.
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
To evaluate the prognostic value of lesionnal Ki on progression-free survival at 2 years and compare it with SUVmax (static 3D acquisition) in patients with metastatic well-differentiated NET
Measured: 2 years
Recidive free survival (RFS)
To evaluate the prognostic value of Ki lesion on progression-free survival at 2 years and compare it with SUVmax (static 3D acquisition) in patients with localised well-differentiated NET
Measured: 2 years
Secondary outcomes (4)
Correlation between lesionnal Ki and immunochemistry markers
Evaluate the statistical correlation between lesional Ki versus SUVmax with NET immunohistochemistry markers expression (SSTR2, SSTR3, and SSTR5; BCL2, Phospho-MTOR expression PD-L1 by tumor cells and immune cells, intra-tumor CD8 + lymphocytes, tumor necrosis surface)
Measured: 0 to 2 years
Predictive value of non-event survival (PFS+RFS)
To evaluate the predictive value of non-event survival (PFS+RFS) with a ΔKi approach in patients receiving an intermediate therapeutic assessment examination (somatostatin analogues or PRRT with 177Lu-DOTATATE), and compare it with a ΔSUVmax approach
Measured: 6 months to 2 years
Correlation between 68Ga-DOTATOC PET/CT and/or 111In-pentetréotide SPECT/CT and 177Lu-DOTATATE SPECT/CT
Evaluate the statistical correlation between the SUVmax assessed with 68Ga-DOTATOC PET/CT and/or 111In-pentetréotide SPECT/CT and 177Lu-DOTATATE SPECT/CT
Measured: 0 to 2 years
Prognostic value of Ki versus usual prognostic parameters
To evaluate the prognostic value on non-event survival (PFS+RFS) at 2 years of Ki and clinical parameters (sex, age), biological (CgA assay), pathology (grade, differentiation, Ki67 expression, BCL2, phospho-MTOR).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start19 Jul 2018
- Primary completion6 Jul 2023
- Study completion6 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576040
- Sponsor's protocol ID
- GAPET-NET (29BRC17.0036)
- Acronym
- GAPET-NET
- Status last verified
- Jun 2025
- First submitted
- 22 Jun 2018
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Interest of a Whole Body Dynamic PET Acquisition in Pre-therapeutic 68Ga-DOTATOC PET/CT for Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT03576040
- Acronym / sponsor ID
- GAPET-NET / GAPET-NET (29BRC17.0036)
- Conditions
- Neuroendocrine Tumors
- Keywords
- Positron Emission Tomography Computed Tomography, whole body dynamic acquisition, Gallium 68
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 6 Jul 2023 (actual)
- Study completion
- 6 Jul 2023 (actual)
- First posted
- 3 Jul 2018 (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.
Neuroendocrine tumors (NET) are a network of rare tumors with common embryological origin. Functional imaging plays a major role in the extension assessment and tumor characterization of NETs. SPECT/CT with 111In-pentetreotide is the recommended test when tumors are well differentiated (grade G1 or G2). It has a real interest in diagnosis, in therapeutic decision-making (in particular by cold somatostatin analogues or in PRRT) and in the systematic follow-up of patients. Nevertheless, SPECT/CT procedure makes for a relatively long review. In addition, scintigraphy has a lower spatial resolution than PET technology and remains of limited interest for signal quantification.
However, the ability to locate and quantitatively measure the absorption of radiopharmaceuticals in the target tissues is a major challenge in oncology for the characterization of the disease.
Recent developments in radiopharmacy have made it possible to target NETs in PET imaging through the use of somatostatin analogues coupled with positron emitters, called 68Ga-DOTA peptides. The diagnostic performance of 68Ga-DOTApeptide PET/CT appears to be superior to SPECT/CT with 111In-pentetreotide. A marketing authorization has thus recently been issued in France for the use of 68Ga-DOTATOC.
Historically, the recommended quantification method in PET was based on the instantaneous measurement in static acquisition (3D) of the maximum of the standardized uptake value (SUVmax). This approach has the disadvantage to measure the signal at a time "t" for a single voxel of the image. Dynamic acquisition methods (4D) have been proposed to extract a radiotracer absorption coefficient (Ki) for a lesion. Several studies have demonstrated the superiority of Ki versus SUVmax in 18FDG PET/CT for the diagnostic management, therapeutic evaluation and prognosis of various solid cancers.
However, no work has validated this approach in PET / CT at 68Ga-DOTATOC as part of the prognostic evaluation of NETs.
The objective of the study is to evaluate the prognostic value of the tumor absorption coefficient Ki resulting from a 4D whole-body dynamic acquisition in PET / CT at 68Ga-DOTATOC in patients with well-differentiated NETs grade I or II according to the WHO classification
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with NET histologically proven and presented in RCP RENATEN at CHRU Brest Primitive: Gastroenteropancreatic, bronchopulmonary or unknown
Key inclusion criteria (4 listed)
- Patient majeur ≥ 18 year old
- Présenting a well differentiated neuroendocrine tumor (G1 ou G2)
- Indication performing a68Ga-DOTATOC PET/CT
- non-opposition
Key exclusion criteria (4 listed)
- Patient <18 years old
- Breastfeeding/ pregnancy
- Other type of tumor
- Refusal of participation
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 |
|---|---|---|
| Whole Body Dynamic 68Ga-DOTATOC PET/CT68Ga-DOTATOC PET-CT will be performed in the nuclear medicine department of the University Hospital of Brest on a Biograph mCT S64 machine (Siemens medical, Erlangen, Germany) "Time of Flight" system after intravenous injection of 150MBq of 68Ga-DOTATOC. In the usual conditions for performing this exam, the patient must remain at a strict rest for 60 minutes following the injection of the tracer and before a static 3D acquisition. For this protocol, a complementary 4D dynamic acquisition (15-60 minutes post-injection) will be performed during this usual rest period. | Device | – |
Primary outcome
Progression free survival (PFS)
Time frame: 2 years
To evaluate the prognostic value of lesionnal Ki on progression-free survival at 2 years and compare it with SUVmax (static 3D acquisition) in patients with metastatic well-differentiated NET
Recidive free survival (RFS)
Time frame: 2 years
To evaluate the prognostic value of Ki lesion on progression-free survival at 2 years and compare it with SUVmax (static 3D acquisition) in patients with localised well-differentiated NET
4 secondary outcomes
Correlation between lesionnal Ki and immunochemistry markers
Time frame: 0 to 2 years
Predictive value of non-event survival (PFS+RFS)
Time frame: 6 months to 2 years
Correlation between 68Ga-DOTATOC PET/CT and/or 111In-pentetréotide SPECT/CT and 177Lu-DOTATATE SPECT/CT
Time frame: 0 to 2 years
Prognostic value of Ki versus usual prognostic parameters
Time frame: 2 years
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 2025.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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?
An observational study of Neuroendocrine Tumors, run by University Hospital, Brest 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 4 inclusion and 4 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 2025. 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?
Progression free survival (PFS) (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2025.