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Neuroendocrine TumoursPhase 2NCT01673906

68-Ga-labeled Octreotide Analogues PET in Duodenal-pancreatic Neuroendocrine Tumours

A Phase 2 study testing Diagnostic work up in people with Neuroendocrine Tumours, run by Azienda USL Reggio Emilia - IRCCS at 21 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The diagnostic work-up of patients suspected of having neuroendocrine tumours (NETs) has traditionally been a challenging issue. The last two decades have been marked by the application to use in the diagnosis of NETs of 3 newly available diagnostic techniques: endoscopic ultrasonography (EUS), multidetector CT… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Neuroendocrine Tumours
What is being tested?
Diagnostic work up
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
21 sitesin 2 countries
Study dates
Aug 2012to 5 Jul 2016
Phase
Phase 2
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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients affected by proved MEN-I, in whom a neoplasm in the duodenal-pancreatic area is suspected.
  • Patients with clinical diagnosis of carcinoid syndrome.
  • Patients with clinical diagnosis of Zollinger-Ellison syndrome.
  • Patients with insulinoma, as proved by fasting test.
  • Patient with clinical pictures and laboratory findings suggesting other functional or non-functional NET.
  • Patients who had previously undergone surgery, including total and subtotal pancreatectomy, or a duodenotomy, intended as curative for a histologically confirmed NET.
Show all 9Show fewer
  • Patients who were diagnosed with NET metastasis with unknown primary location of the disease.
  • Patients undergoing diagnostic work-up for a periduodenal or pancreatic lesion incidentally found during abdominal ultrasound (not performed for suspicion of a NET) and with ultrasonographic characteristics (rounded, hypoechoic or egg-eye, well demarcated) suspicious for NET.
  • Patients undergoing diagnostic work-up for a periduodenal or pancreatic lesion incidentally found during TC (not performed for suspicion of a NET) and with radiological characteristics (well demarcated, hypervascular) suspicious for NET.

Who cannot join

  • Patient unwilling, or unable to consent.
  • Pregnancy, or lactation.
  • Age <18 years
  • Known diagnosis of duodenal-pancreatic NET.
  • Patients with concomitant life-threatening disease.
  • Patients who had already undergone PET or EUS, in the last six months. In particular patients should be excluded from the study, when a lesion in the duodenal-pancreatic area, with characteristic suspicious for a NET, is incidentally diagnosed by PET, or EUS, or when a previously unsuspected diagnosis of NET is suggested by EUS-FNA of a pancreatic lesion.
  • Patients who had previously undergone total gastrectomy or pancreatectomy will be included in the study, but they will not undergo EUS.

Trial locations and contacts

21 sites in 2 countries.

21 sites in 2 countries

Italy20 sites

  • Enrico Papini

    Albano Laziale, Roma

  • Nadia Cremonini

    Bologna, Bologna

  • Fernando Cirillo

    Cremona, Cremona

  • Diego Ferone

    Genova, Genova

  • Laura Scaltriti

    Guastalla, Reggio Emilia, 42100

  • Giovanna Pepe

    Milan, Milano

  • Rita Conigliaro

    Modena, Modena, 41121

  • Luppi Gabriele

    Modena, Modena

  • Pellegrino Crafa

    Parma, Parma, 43121

  • Piero Ferolla

    Perugia, Perugia

  • Antonio Chella

    Pisa, Pisa

  • ASMN IRCCS Reggio Emilia

    Reggio Emilia, RE, 42100

  • Roberto Baldelli

    Roma, Roma

  • Vittoria Rufini

    Roma, Roma

  • Claudio De Angelis

    Torino, Torino

  • Marco Gallo

    Torino, Torino

  • Paolo Limone

    Torino, Torino

  • Franco Grimaldi

    Udine, Udine

  • Massimo Falconi

    Verona, Verona

  • Roberto Castello

    Verona, Verona

Other trials in Italy

Austria1 site

  • Irene Virgolini

    Innsbruck, Innsbruck

Other trials in Austria

About this study

Official title: Accuracy and Clinical Impact of 68-Ga-labeled Octreotide Analogues PET in Diagnosis and Staging of Duodenal-pancreatic Neuroendocrine Tumours; Proposal of a Multicenter, Prospective Clinical Trial

The diagnostic work-up of patients suspected of having neuroendocrine tumours (NETs) has traditionally been a challenging issue. The last two decades have been marked by the application to use in the diagnosis of NETs of 3 newly available diagnostic techniques: endoscopic ultrasonography (EUS), multidetector CT (MDCT), and more recently, positron emission tomography using 68Ga-labelled octreotide analogues (PET). In a prospective study conducted at a single referral centre that compared PET with conventional somatostatin receptor scintigraphy and MDCT in diagnosis, staging and follow-up of patients affected by NET, PET detected more primary and secondary lesions than other methods. Recent studies investigated the clinical impact of PET in the management of patients affected by NET, previously studied by MDCT. The investigators recently reported the results of the investigation of 19 patients suspected of having primary pancreatic NET and studied by PET, MDCT and EUS. The investigators preliminary data suggest that PET may be slightly more sensitive than MDCT in detecting small (<2cm) pancreatic lesions; accuracy of PET and EUS is probably similar. No prospective study has yet been devoted to evaluate the accuracy of PET in the diagnosis and staging of primary duodenal-pancreatic NETs. Furthermore, the clinical impact of the adjunct of PET to the traditional protocols of diagnosis and staging of these tumours waits to be thoroughly evaluated. Thus the appropriate place of PET in the diagnostic algorithm of patients suspected of having duodenal-pancreatic NET remains undefined.

The main aim of this project is to prospectively compare the accuracy of PET and MDCT in the diagnosis and staging of patients suspected of having duodenal-pancreatic NETs. The investigators hypothesised that PET is superior to MDCT in the diagnosis of these neoplasm (the dimension of the study sample is estimated in order to detect a 10% difference). The impact of PET on management plan of affected patients will also be evaluated. As a secondary endpoint of the study, the investigators will compare EUS, PET and MDCT in the diagnosis of primary duodenal-pancreatic NET. The study is designed as a multicentre, prospective, non-randomised clinical trial. All patients will undergo MDCT, PET and EUS in this fixed order.

Being tested
Diagnostic work up
Keywords
positron-emission tomography, neuroendocrine tumors, endosonography, tomography, X-ray computed, biopsy, fine needle, sensitivity and sensibility
Medical subject headings
Neuroendocrine Tumors, Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diagnostic work upDrug

    Patients will undergo MDCT, PET and EUS. Every attempt will be made to achieve a pre-operative cytologic diagnosis of any primary lesion by EUS-FNA. All diagnostic tests (MDCT, PET, EUS) should be performed during a two month time span, in this fixed order. The nuclear medicine doctor will be blinded of findings of MDCT. The gastroenterologist will be blinded about the findings of MDCT and PET until he has completed the diagnostic EUS. For ethical reasons, the findings of MDCT and PET will be disclosed to her/him, while the patient is still sedated in the operating room, just before the FNA. The minimal technical requirement for the techniques, the requested levels of clinical competence of the operators and the procedure for critical revision of radiological and cytological and histological specimens are detailed in the protocol. For PET any 68Ga -labeled-octreotide analogue will be allowed. Before EUS, an extended-esophagogastroduodenoscopy (until the Treitz) until will be performed.

Study groups in NCT01673906
Study groupRoleWhat they receive
Diagnostic work upExperimentalThe patients enrolled in the study (see below), with a consistent clinical suspicion of a primary duodenal-pancreatic NET.
Receives: Drug: Diagnostic work up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accuracy of the diagnostic test.

    Accuracy was computed as: (number of true positives + true negatives)/(number + true positives + true negatives + false positives + false negatives). Accuracy of MDCT and PET in the diagnosis of primary duodenal-pancreatic NET will be calculated on a patient basis and they will be compared using McNemar test. Reference standard will be considered the diagnoses of primary NET, when supported by unambiguous cytology, histology or by at least one year of follow up.In cases of disagreement between cytological and histological findings, histology will be the gold standard.

    Measured: one year

  2. Accuracy of the diagnostic test (after exclusion of patients enrolled due to a incidentally diagnosed lesion)

    Accuracy was calculated as above, but based on subjects matching criteria 1-7 of the list of clinical situations suggestive for NET (see below, inclusion criteria). Patients with a lesion suspicion of NET incidentally diagnosed during abdominal ultrasound or MDCT not performed for clinical suspicion of NET were excluded.

    Measured: one year

Secondary outcomes (5)

  1. Number of Participants with Adverse Events as a Measure of Safety.

    Number of patients with adverse events of each procedure: PET, MDCT, endoscopic ultrasonography-fine needle aspiration (EUS-FNA)

    Measured: one year

  2. Sensitivity of the diagnostic tests.

    Sensitivity (Number of true positive results/number of true positive + false negative results) of the diagnostic tests in the diagnosis of primary duodenal-pancreatic NET. Sensitivity of each diagnostic test (MDCT, PET, EUS) will be calculated separately on patient (number of true affected patients/number of true affected + number of false non affected patients) and on lesion basis (number of true positive lesions/number of true positive + false positive lesions)with its 95% confidence interval based on normal approximation.Reference standard will be considered the diagnoses of primary NET, when supported by unambiguous cytology, histology or by at least one year of follow up.In cases of disagreement between cytological and histological findings, histology will be the gold standard.

    Measured: one year

  3. Specificity of the diagnostic tests.

    Specificity (Number of true negative results/number of true negative + false positive results) of the diagnostic tests in the diagnosis of primary duodenal-pancreatic NET. Specificity of each diagnostic test (MDCT, PET, EUS) will be calculated separately on patient (number of true non affected patients/number of true non affected + number of false affected patients) and on lesion basis (number of true negative lesions/number of true negative positive + false positive lesions)with its 95% confidence interval based on normal approximation.Reference standard will be considered the diagnoses of primary NET, when supported by unambiguous cytology, histology or by at least one year of follow up.In cases of disagreement between cytological and histological findings, histology will be the gold standard.

    Measured: one year

  4. Clinical impact of PET.

    Changes in management plan in consequence of PET results. Prior to receiving the results of the PET scans, the referring clinician will be required to explicit a management plan for the patient. Following the release of the PET results, a second management plan will be recorded, including any changes resulting from the PET findings. The number of patients with changes in their management plan will be recorded.

    Measured: one year

  5. Diameter of lesions.

    Median diameter (cm) and ranges of lesions diagnosed by each technique will be calculated.

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionAug 2015
  4. Study completion5 Jul 2016

Resources

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 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01673906
Sponsor's protocol ID
2012-000994-22
Other IDs
2012-000994-22
Status last verified
Mar 2018
First submitted
9 Aug 2012
Last updated
24 Jun 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Gabriel M, Decristoforo C, Kendler D, Dobrozemsky G, Heute D, Uprimny C, Kovacs P, Von Guggenberg E, Bale R, Virgolini IJ. 68Ga-DOTA-Tyr3-octreotide PET in neuroendocrine tumors: comparison with somatostatin receptor scintigraphy and CT. J Nucl Med. 2007 Apr;48(4):508-18. doi: 10.2967/jnumed.106.035667.

    PubMed 17401086

  • Ambrosini V, Campana D, Bodei L, Nanni C, Castellucci P, Allegri V, Montini GC, Tomassetti P, Paganelli G, Fanti S. 68Ga-DOTANOC PET/CT clinical impact in patients with neuroendocrine tumors. J Nucl Med. 2010 May;51(5):669-73. doi: 10.2967/jnumed.109.071712. Epub 2010 Apr 15.

    PubMed 20395323

  • Versari A, Camellini L, Carlinfante G, Frasoldati A, Nicoli F, Grassi E, Gallo C, Giunta FP, Fraternali A, Salvo D, Asti M, Azzolini F, Iori V, Sassatelli R. Ga-68 DOTATOC PET, endoscopic ultrasonography, and multidetector CT in the diagnosis of duodenopancreatic neuroendocrine tumors: a single-centre retrospective study. Clin Nucl Med. 2010 May;35(5):321-8. doi: 10.1097/RLU.0b013e3181d6677c.

    PubMed 20395703

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Diagnostic work up in people with Neuroendocrine Tumours, run by Azienda USL Reggio Emilia - IRCCS at 21 sites in 2 countries.

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 9 inclusion and 7 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 24 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 21 sites in Italy, Austria. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Accuracy of the diagnostic test. (time frame: one year). 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?

On the ClinicalTrials.gov record for NCT01673906, which also lists 3 linked publications.

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 24 Jun 2025.

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