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CompletedNCT0174709668-DOTANOC-GEPUpdated Jan 21, 2022

TEP With 68-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors

An interventional study of 68-Ga-DOTANOC in Patients With Gastroenteropancreatic Neuroendocrine Tumors, sponsored by Nantes University Hospital. Completed at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-21.

Sponsored by Nantes University Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Patients With Gastroenteropancreatic Neuroendocrine Tumors

Keywords

  • Gastroenteropancreatic Neuroendocrine Tumors
  • immuno PET (iPET)
  • Gallium (68-Ga)
  • DOTANOC
03

In context

Neuroendocrine Tumors

676 studies on the registry are indexed under Neuroendocrine Tumors; 169 are open to participants now.

This study's enrollment of 130 is above the median of 42 across 464 interventional studies indexed under Neuroendocrine Tumors.

Browse Neuroendocrine Tumors studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
130 participants (actual)

Study arms

  • Experimental
    68-Ga-DOTANOC

    Drug: 68-Ga-DOTANOC

Interventions

  • Drug68-Ga-DOTANOC
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 months

Secondary outcomes

  1. Compare the diagnostic performance of PET / CT with 68Ga-DOTANOC with the standard process

    Time frame: 12 months

Other outcomes

  1. Assess the clinical impact of PET / CT 68 Ga-DOTANOC in terms of specificity and predictive value for the detection of locations of GEP.

    Time frame: 12 months

  2. 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.

    Time frame: 12 months

  3. Assess the value of PET / CT 68 Ga-DOTANOC in terms of specificity and predictive value for the detection of locations of GEP.

    Time frame: 12 months

  4. Tolerance of 68-Ga-DOTANOC

    the vital signs and clinical tolerance will be assess during the 2 hours following injection of the radiopharmaceutical.

    Time frame: 12 mois

07

Study locations

5 sites
  • Angers Hospital
    Angers, 49100, France
  • Hôpital Beaujon
    Clichy, 92110, France
  • Hôpital Bichat
    Paris, 75018, France
  • Institut de Cancérologie de l'Ouest, René Gauducheau
    Saint Herblain, 44805, France
  • Nantes Hospital
    Saint Herblain, 44805, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01747096
Lead sponsor
Nantes University Hospital
Responsible party
Sponsor
First posted
Dec 11, 2012
Start date
Nov 2012
Primary completion
May 2016
Completion
May 2016
Last update
Jan 21, 2022

Study contacts

Catherine Ansquer, MD
principal investigator · Nantes Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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