Know Cancer

or
forgot password

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


Phase 2
18 Years
90 Years
Open (Enrolling)
Both
Neuroendocrine Tumours

Thank you

Trial Information

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


Inclusion Criteria:



1. Patients affected by proved MEN-I, in whom a neoplasm in the duodenal-pancreatic area
is suspected.

2. Patients with clinical diagnosis of carcinoid syndrome.

3. Patients with clinical diagnosis of Zollinger-Ellison syndrome.

4. Patients with insulinoma, as proved by fasting test.

5. Patient with clinical pictures and laboratory findings suggesting other functional or
non-functional NET.

6. Patients who had previously undergone surgery, including total and subtotal
pancreatectomy, or a duodenotomy, intended as curative for a histologically confirmed
NET.

7. Patients who were diagnosed with NET metastasis with unknown primary location of the
disease.

8. 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.

9. 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.

Exclusion criteria:

1. Patient unwilling, or unable to consent.

2. Pregnancy, or lactation.

3. Age <18 years

4. Known diagnosis of duodenal-pancreatic NET.

5. Patients with concomitant life-threatening disease.

6. 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.

7. Patients who had previously undergone total gastrectomy or pancreatectomy will be
included in the study, but they will not undergo EUS.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Accuracy of the diagnostic test.

Outcome Description:

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.

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Lorenzo Camellini, MD

Investigator Role:

Study Director

Investigator Affiliation:

Gastroenterology and Digestive Endoscopy Unit, Santa Maria Hospital, Reggio Emilia, Italy.

Authority:

Italy: The Italian Medicines Agency

Study ID:

2012-000994-22

NCT ID:

NCT01673906

Start Date:

August 2012

Completion Date:

August 2015

Related Keywords:

  • Neuroendocrine Tumours
  • positron-emission tomography
  • neuroendocrine tumors
  • endosonography
  • tomography, X-ray computed
  • biopsy, fine needle
  • sensitivity and sensibility
  • Neuroendocrine Tumors
  • Adenoma, Islet Cell

Name

Location