Patients With Gastroenteropancreatic Neuroendocrine Tumors68-DOTANOC-GEPNCT01747096
TEP With 68-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors
A study testing 68-Ga-DOTANOC in people with Patients With Gastroenteropancreatic Neuroendocrine Tumors, run by Nantes University Hospital at 5 sites in France.
Trial summary
Evaluation of the diagnostic performance of PET / CT with 68Ga-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors with comparison with other techniques used in routine clinical practice (octreoscan ® ; multiphase SPECT / CT, MRI or endoscopy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Gastroenteropancreatic Neuroendocrine Tumors
- What is being tested?
- 68-Ga-DOTANOC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 5 sitesFrance
- Study dates
- Nov 2012to May 2016
- 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
- Age over 18 years
- effective contraception or exclusion of pregnancy dosage of beta-HCG in women of childbearing age
- Fortuitous discovery of suggestive tumors of TE-GEP with well documented conventional imaging (multiphase CT; MRI, US endoscopy) associated or not associated with clinical or biological signs of TE-GEP tumors (increase in tumor markers) OR
- Histologically proven GEP-TE (WHO classification 2010 (26) well differentiated in the initial staging OR
- Suspicion of recurrence or progression of well differentiated TE-GEP tumors on conventional imaging or laboratory tests (increase in tumor markers) OR
- Clinical or biological syndrome strongly suggestive of digestive endocrine disease without identification of lesions with conventional imaging
- Informed consent and patient's written
- Affiliation to an insurance
Who cannot join
- Multiple endocrine neoplasia
- TE GEP tumor not differentiated
- Pregnancy and lactation
- Persons protected by law
- Restlessness, inability to lie still hold at least 1 hour; Claustrophobia
- Poor compliance predictable or inability to undergo medical test for geographical, social or psychological
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- Treatment with radiotherapy, chemotherapy or other antitumor treatment within 6 weeks of previous morphological and scintigraphic examinations. In case of treatment with somatostatin analogues delayed, scans will be performed 4 weeks after the last injection. However, a shorter period may be observed to avoid to do again the initial assessment exams.
- malignancy except basal cell cancers and cancer in situ of the cervix
- Contraindication of injection of a contrast agent necessary for the production of multiphase scanner.
- Patients who had a CT scan without injection of contrast material can not participate in the study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Angers Hospital
Angers, 49100
Hôpital Beaujon
Clichy, 92110
Hôpital Bichat
Paris, 75018
Institut de Cancérologie de l'Ouest, René Gauducheau
Saint-Herblain, 44805
Nantes Hospital
Saint-Herblain, 44805
About this study
Official title: Diagnostic, Prospective, Comparative, Multicentric Study of the PET / CT With 68Ga-DOTANOC Versus Conventional Imaging Procedures (octréoscan ® Scintigraphy and CT / MRI) in the Assessment of in Gastroenteropancreatic Neuroendocrine Tumors
Evaluation of the diagnostic performance of PET / CT with 68Ga-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors with comparison with other techniques used in routine clinical practice (octreoscan ® ; multiphase SPECT / CT, MRI or endoscopy).
Therapeutic impact and safety of PET / CT with 68Ga-DOTANOC will also be assessed. Expected results are a confirmation of the superiority of 68Ga-PET DOTANOC versus scintigraphy octreoscan ®, with a potential impact on the therapeutic management of patients.
- Being tested
- 68-Ga-DOTANOC
- Keywords
- Gastroenteropancreatic Neuroendocrine Tumors, immuno PET (iPET), Gallium (68-Ga), DOTANOC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68-Ga-DOTANOCDrug
| Study group | Role | What they receive |
|---|---|---|
| 68-Ga-DOTANOC | Experimental | Not described Receives: Drug: 68-Ga-DOTANOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Gastroenteropancreatic Neuroendocrine Tumors lesions in the initial assessment or during the search of recurrence.
Reference to the gold standard (that will be obtained from the data of histology and / or follow-up imaging at least 12 months
Measured: 12 months
Secondary outcomes (1)
Compare the diagnostic performance of PET / CT with 68Ga-DOTANOC with the standard process
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Gastroenteropancreatic Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Ansquer, MD, Principal investigator, Nantes Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01747096
- Sponsor's protocol ID
- BRD/11/05-K
- Acronym
- 68-DOTANOC-GEP
- Status last verified
- Jul 2016
- First submitted
- 13 Nov 2012
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic, Prospective, Comparative, Multicentric Study of the PET / CT With 68Ga-DOTANOC Versus Conventional Imaging Procedures (octréoscan ® Scintigraphy and CT / MRI) in the Assessment of in Gastroenteropancreatic Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT01747096
- Acronym / sponsor ID
- 68-DOTANOC-GEP / BRD/11/05-K
- Keywords
- Gastroenteropancreatic Neuroendocrine Tumors, immuno PET (iPET), Gallium (68-Ga), DOTANOC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 11 Dec 2012 (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.
Evaluation of the diagnostic performance of PET / CT with 68Ga-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors with comparison with other techniques used in routine clinical practice (octreoscan ® ; multiphase SPECT / CT, MRI or endoscopy).
Therapeutic impact and safety of PET / CT with 68Ga-DOTANOC will also be assessed. Expected results are a confirmation of the superiority of 68Ga-PET DOTANOC versus scintigraphy octreoscan ®, with a potential impact on the therapeutic management of patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68-Ga-DOTANOC | Experimental | Drug: 68-Ga-DOTANOC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age over 18 years
- effective contraception or exclusion of pregnancy dosage of beta-HCG in women of childbearing age
- Fortuitous discovery of suggestive tumors of TE-GEP with well documented conventional imaging (multiphase CT; MRI, US endoscopy) associated or not associated with clinical or biological signs of TE-GEP tumors (increase in tumor markers) OR
- Histologically proven GEP-TE (WHO classification 2010 (26) well differentiated in the initial staging OR
- Suspicion of recurrence or progression of well differentiated TE-GEP tumors on conventional imaging or laboratory tests (increase in tumor markers) OR
Key exclusion criteria (10 listed)
- Multiple endocrine neoplasia
- TE GEP tumor not differentiated
- Pregnancy and lactation
- Persons protected by law
- Restlessness, inability to lie still hold at least 1 hour; Claustrophobia
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 |
|---|---|---|
| 68-Ga-DOTANOC | Drug | 68-Ga-DOTANOC |
Primary outcome
Detection of Gastroenteropancreatic Neuroendocrine Tumors lesions in the initial assessment or during the search of recurrence.
Time frame: 12 months
Reference to the gold standard (that will be obtained from the data of histology and / or follow-up imaging at least 12 months
1 secondary outcome
Compare the diagnostic performance of PET / CT with 68Ga-DOTANOC with the standard process
Time frame: 12 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 21 Jan 2022.
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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.
Catherine Ansquer, MD principal investigator
Nantes Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68-Ga-DOTANOC in people with Patients With Gastroenteropancreatic Neuroendocrine Tumors, run by Nantes University Hospital at 5 sites 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 8 inclusion and 10 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 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Detection of Gastroenteropancreatic Neuroendocrine Tumors lesions in the initial assessment or during the search of recurrence. (time frame: 12 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 21 Jan 2022.