TEP With 68-DOTANOC in Gastroenteropancreatic Neuroendocr... | NCT01747096

Studies
TEP With 68-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors

NCT01747096

Sponsor

Nantes University Hospital

Status

Completed

Last Update Posted

Jan 21, 2022Actual

Enrollment

130Actual

Phase

Not Applicable

Conditions

Patients With Gastroenteropancreatic Neuroendocrine Tumors

Interventions

68-Ga-DOTANOC

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Nov 13, 2012

First Submission Date that Met QC Criteria

Dec 10, 2012

First Posted Date

Dec 11, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2022

Last Update Posted Date

Jan 21, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Actual

Label	Type	Description	Intervention Names
68-Ga-DOTANOC	Experimental		Drug: 68-Ga-DOTANOC

Name	Type	Description	Arm Group Labels	Other Names
68-Ga-DOTANOC	Drug		68-Ga-DOTANOC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	12 months

Secondary Outcomes

Measure	Description	Time Frame
Compare the diagnostic performance of PET / CT with 68Ga-DOTANOC with the standard process		12 months

Other Outcomes

Measure	Description	Time Frame
Assess the clinical impact of PET / CT 68 Ga-DOTANOC in terms of specificity and predictive value for the detection of locations of GEP.		12 months
Assess the relevance of decisions of PET / CT 68 Ga-DOTANOC in terms of specificity and predictive value for the detection of locations of GEP.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Angers Hospital		Angers		49100	France
Hôpital Beaujon