## Protocol Section
### Identification Module
**NCT ID:** NCT01485679

**Brief Title:** 18 Fluoro-deoxy-glucose Positrons Emission Tomography Combined With Computed Tomography (18-FDG TEP-CT ) in the Diagnosis of the Degeneration of Intraductal Papillary Mucinous Tumor of the Pancreas

**Official Title:** Evaluation of 18 Fluoro-deoxy-glucose Positrons Emission Tomography Combined With Computed Tomography (18-FDG TEP-CT ) in the Diagnosis of the Degeneration of Intraductal Papillary Mucinous Tumor of the Pancreas

#### Organization Study ID Info
**ID:** BRD/10/06-P
#### Organization
**Class:** OTHER
**Full Name:** Nantes University Hospital
### Status Module
#### Completion Date
**Date:** 2015-04

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-05-18

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-05-17

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-04

**Type:** ACTUAL

#### Start Date
**Date:** 2011-01

**Status Verified Date:** 2015-10

#### Study First Post Date
**Date:** 2011-12-05
**Type:** ESTIMATED
**Study First Submit Date:** 2011-08-26
**Study First Submit QC Date:** 2011-12-01
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Nantes University Hospital

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** The aim of the study is to evaluate whether the TEP-CT can be sensitive and specific in identifying degenerated intraductal papillary mucinous tumor of the pancreas.The results will be compared to those obtained by the pathological analysis of the removed piece of pancreas.

**Detailed Description:** Before surgery is undertaken, a 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography (18-FDG TEP-CT ) will be performed. The primary outcome of this study is to compare results of the TEP-CT with those obtained by the pathological analysis of the removed piece of pancreas.

### Conditions Module

**Conditions:**

- Tumor

**Keywords:**

- 18 fluoro deoxy glucose positrons emission tomography combined with computed tomography,

- Patients with intraductal papillary mucinous tumor of the pancreas

- intraductal papillary mucinous

- pancreas

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 126

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography

**Label:** positrons emission tomography

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- positrons emission tomography

**Description:** 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography

**Name:** 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** TEP-CT of the different 5 parts of the pancreas (head, uncus, isthmi, body and tail) will be interpreted by nuclearity Doctors. TEP-CT will be considered positive if there is a pathological fixation of the 18-FDG , defined as any focal or diffuse fixation of 18-FDG above the background level of fixation in the pancreas.

The anatomopathological analysis of the piece of pancreas removed during the ablative surgery will be considered as positive if the degree of dysplasia seen for each part of the pancreas is "infiltrating carcinoma".

Results will then be compared in term of specificity.

**Measure:** Specificity of TEP-CT to point out malignant lesions in pancreas, the gold standard being the anatomopathological analysis of the piece of pancreas removed during the surgery.

**Time Frame:** 3 months

#### Secondary Outcomes

**Description:** TEP-CT of the different 5 parts of the pancreas (head, uncus, isthmi, body and tail) will be interpreted by nuclearity Doctors. TEP-CT will be considered positive if there is a pathological fixation of the 18-FDG , defined as any focal or diffuse fixation of 18-FDG above the background level of fixation in the pancreas.

The anatomopathological analysis of the piece of pancreas removed during the ablative surgery will be considered as positive if the degree of dysplasia seen for each part of the pancreas is "infiltrating carcinoma".

Results will then be compared in term of sensitivity.

**Measure:** Sensitivity of TEP-CT to point out malignant lesions in pancreas, the gold standard being the anatomopathological analysis of the piece of pancreas removed during the surgery.

**Time Frame:** 3 months

**Description:** Result of conventional devices (such as computed tomography, magnetic resonance cholangiopancreatography or endoscopic ultrasound) will be considered positive if diagnosis is "malignant lesion" or "probable malignant lesion". The 5 parts of the pancreas will be examined.

**Measure:** Comparison of specificity of the TEP-CT to detect malignant lesions in pancreas versus specificity of conventional devices, the gold standard being the anatomopathological analysis results

**Time Frame:** 3 months

**Measure:** Number of patients for which metastasis will be detected through TEP-CT and confirmed by biopsy and/or conventional specific device

**Time Frame:** 3 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Adults with age equal or above 18
* Patients diagnosed with intraductal papillary mucinous tumor with surgical indication and for whom it will be possible to have the pathological analysis of the removed piece of pancreas.
* if woman being of childbearing potential, woman taking contraceptive measures
* Patient able to understand benefits and risks of protocol
* Subject affiliated to French health insurance (Social Security)
* Informed consent form signed

Exclusion Criteria:

* Patients not fulfilling inclusion criteria
* Pancreatic surgery or radiotherapy in the pancreatic zone within 4 the months preceding the TEP-CT
* Chemotherapy within 2 the months preceding the TEP-CT
* Acute pancreatitis within 2 the months preceding the TEP-CT
* Pregnant women or breast-feeding women refusing to temporary stop it
* Diabetes not equilibrated (checked by glycemia and glycosylated hemoglobin (HbA1c) at inclusion) or Fasting blood glucose below 7mmol/L (126 g/L before the TEP)
* Patients with claustrophobia
* Patients not accepted under the anesthesia point of view

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Amiens

**Country:** France

**Facility:** CHU Nord

**Zip:** 80080

**Location 2:**

**City:** Bordeaux

**Country:** France

**Facility:** Maison de Haut Lévêque CHU

**Zip:** 33604

**Location 3:**

**City:** Clichy

**Country:** France

**Facility:** Hôpital Beaujon APHP

**Zip:** 92110

**Location 4:**

**City:** Lille

**Country:** France

**Facility:** Hôpital C Huriez

**Zip:** 59037

**Location 5:**

**City:** Lyon

**Country:** France

**Facility:** Hospices Civils de Lyon

**Zip:** 69437

**Location 6:**

**City:** Marseille

**Country:** France

**Facility:** Institut Paoli Calmettes

**Zip:** 13273

**Location 7:**

**City:** Marseille

**Country:** France

**Facility:** CHU Nord

**Zip:** 13915

**Location 8:**

**City:** Nantes

**Country:** France

**Facility:** CHU

**Zip:** 44093

**Location 9:**

**City:** Paris

**Country:** France

**Facility:** Hôpital St-Antoine

**Zip:** 75012

**Location 10:**

**City:** Rennes

**Country:** France

**Facility:** CHU Hôpital Pontchaillou

**Zip:** 35033

**Location 11:**

**City:** Strasbourg

**Country:** France

**Facility:** Hôpital de Hautepierre

**Zip:** 67098

**Location 12:**

**City:** Toulouse

**Country:** France

**Facility:** CHU Rangueil

**Zip:** 31059

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009369

- Term: Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000004701

- Term: Endocrine Gland Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000010182

- Term: Pancreatic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13110

- Name: Pancreatic Neoplasms

- Relevance: HIGH

- As Found: Tumors of the Pancreas

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7863

- Name: Endocrine Gland Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13102

- Name: Pancreatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4387

- Name: Pancreatic Cancer

- Relevance: HIGH

- As Found: Tumors of the Pancreas

### Condition Browse Module - Meshes

- ID: D000010190

- Term: Pancreatic Neoplasms

### Intervention Browse Module - Ancestors

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000998

- Term: Antiviral Agents

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: Gast

- Name: Gastrointestinal Agents

### Intervention Browse Module - Browse Leaves

- ID: M21686

- Name: Fluorodeoxyglucose F18

- Relevance: LOW

- As Found: Unknown

- ID: M7043

- Name: Deoxyglucose

- Relevance: HIGH

- As Found: Velban

- ID: M22554

- Name: Pancrelipase

- Relevance: LOW

- As Found: Unknown

- ID: M13114

- Name: Pancreatin

- Relevance: LOW

- As Found: Unknown

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

- ID: M4314

- Name: Antiviral Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000003847

- Term: Deoxyglucose

### Misc Info Module

- Version Holder: 2024-05-24
