Gastro-Entero-Pancreatic Tumors (GEPs)DOTATATENETNCT02150408
Evaluation of PET-CT Using Somatostatin Agonists Labeled With Gallium68 in Neuroendocrine Tumors
A study testing PET-CT in people with Gastro-Entero-Pancreatic Tumors (GEPs), run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Gastro-Entero-Pancreatic tumors (GEPs) are a subset of Neuroendocrine tumors (NETs) derived from the primitive gut and include digestive and bronchial NETs. Historically, the gold standard in their functional exploration is the "conventional" somatostatin receptors scintigraphy (SRS) labeled with Indium-111… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastro-Entero-Pancreatic Tumors (GEPs)
- What is being tested?
- PET-CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 22 Apr 2014to 5 Apr 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Age ≥ 18,
- Patient with one of the following situations : suspicion of GEP, initial staging of non-metastatic GEP, GEP with unknown primary tumor, Restaging of GEP justifying focused therapeutic approach
- Reference imaging within the last 3 months: multiphasic thoracoabdominal CT scan, liver MRI and SRS (SPECT/CT).
Who cannot join
- Pregnant or breast-feeding woman
- Other cancer disease
- GEP with grade 3 tumours
- Non GEP TNE (paragangliome, medullar thyroid cancer)
Trial locations and contacts
1 site in 1 country.
About this study
Gastro-Entero-Pancreatic tumors (GEPs) are a subset of Neuroendocrine tumors (NETs) derived from the primitive gut and include digestive and bronchial NETs.
Historically, the gold standard in their functional exploration is the "conventional" somatostatin receptors scintigraphy (SRS) labeled with Indium-111 (Octreoscan®). This reference imaging is complementary to Tomography (CT) and liver MRI. However SRS sensitivity is moderate (60 %), because of its intrinsic detection limits, which could delay the diagnosis or lead to inappropriate therapy.
The use of somatostatin agonists (DOTATOC, DOTATATE, DOTANOC), radiolabeled with gallium-68 (68Ga) enables targeting of Somatostatin receptors (SSTRs) with a PET resolution. This has improved diagnosis of TNE with a gain in sensitivity of over 20% compared to SRS. Furthermore, patient irradiation and imaging protocol are significantly reduced.
- Conditions
- Gastro-Entero-Pancreatic Tumors (GEPs)
- Being tested
- PET-CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-CTOther
| Study group | Role | What they receive |
|---|---|---|
| assesment by 68Ga-DOTATATE PET-CT | Experimental | Not described Receives: Other: PET-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
interest of the realization of 68Ga-DOTATATE PET-CT in the detection of tumor sites in TNE diagnosis, staging and restaging
Measured: 12-15 months
Secondary outcomes (1)
therapeutic impact of 68Ga-DOTATATE PET-CT in addition to reference imaging (SRS, CT, MRI): we will document the rate of changes in treatment options induced by PET-CT
Measured: 12-15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study start22 Apr 2014
- Primary completion24 May 2017
- Study completion5 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-Entero-Pancreatic Tumors (GEPs)Studies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David TAIEB, MD, Principal investigator, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150408
- Sponsor's protocol ID
- 2013-27
- Acronym
- DOTATATENET
- Status last verified
- Apr 2023
- First submitted
- 26 May 2014
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of PET-CT Using Somatostatin Agonists Labeled With Gallium68 in Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT02150408
- Acronym / sponsor ID
- DOTATATENET / 2013-27
- Conditions
- Gastro-Entero-Pancreatic Tumors (GEPs)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 22 Apr 2014 (actual)
- Primary completion
- 24 May 2017 (actual)
- Study completion
- 5 Apr 2023 (actual)
- First posted
- 29 May 2014 (estimated)
- 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.
Gastro-Entero-Pancreatic tumors (GEPs) are a subset of Neuroendocrine tumors (NETs) derived from the primitive gut and include digestive and bronchial NETs.
Historically, the gold standard in their functional exploration is the "conventional" somatostatin receptors scintigraphy (SRS) labeled with Indium-111 (Octreoscan®). This reference imaging is complementary to Tomography (CT) and liver MRI. However SRS sensitivity is moderate (60 %), because of its intrinsic detection limits, which could delay the diagnosis or lead to inappropriate therapy.
The use of somatostatin agonists (DOTATOC, DOTATATE, DOTANOC), radiolabeled with gallium-68 (68Ga) enables targeting of Somatostatin receptors (SSTRs) with a PET resolution. This has improved diagnosis of TNE with a gain in sensitivity of over 20% compared to SRS. Furthermore, patient irradiation and imaging protocol are significantly reduced.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| assesment by 68Ga-DOTATATE PET-CT | Experimental | Other: PET-CT |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Age ≥ 18,
Key exclusion criteria (4 listed)
- Pregnant or breast-feeding woman
- Other cancer disease
- GEP with grade 3 tumours
- Non GEP TNE (paragangliome, medullar thyroid cancer)
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 |
|---|---|---|
| PET-CT | Other | assesment by 68Ga-DOTATATE PET-CT |
Primary outcome
interest of the realization of 68Ga-DOTATATE PET-CT in the detection of tumor sites in TNE diagnosis, staging and restaging
Time frame: 12-15 months
1 secondary outcome
therapeutic impact of 68Ga-DOTATATE PET-CT in addition to reference imaging (SRS, CT, MRI): we will document the rate of changes in treatment options induced by PET-CT
Time frame: 12-15 months
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 6 Apr 2023.
Related trials for Gastro-Entero-Pancreatic Tumors (GEPs)
Recruiting
Evaluating the roLe of Multiplexed PET Imaging in the Detection and Staging of hepatocellulaR Carcinoma and gAstro-entero-pancreatic Tumors
Hepatocellular Carcinoma (HCC), Gastro-Entero-Pancreatic Tumors (GEPs)
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.
David TAIEB, MD principal investigator
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET-CT in people with Gastro-Entero-Pancreatic Tumors (GEPs), run by Assistance Publique Hopitaux De Marseille 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 3 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 6 Apr 2023. 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?
interest of the realization of 68Ga-DOTATATE PET-CT in the detection of tumor sites in TNE diagnosis, staging and restaging (time frame: 12-15 months). 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 6 Apr 2023.