Clinical trial NCT01881620: PET Enhanced CT Scan Performance in Cancer
Official title: PET / Enhanced CT Scan Performance in Cancer (Positron Emission Tomography Combined With Computed Tomography or Vascular Contrast CT Scan). COMBI TEP Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Disease Progression
Keywords: PET scan
CT scan
Diagnostic performance
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
First posted: 2013-06-19
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Hypothesis:

The investigators would like to demonstrate that diagnosis performance of PET/CT scan without and with contrast agent (COMBI TEP), are equivalent or better than those of PET/ non enhanced CT scan (PET scan) associated with an enhanced CT scan. This research project is a pilot study given the few available data concerning this imaging exam reproducibility.

This study is a prospective single center study.

Detailed description: Hypothesis:

We would like to demonstrate that diagnosis performance of PET/CT scan without and with contrast agent (COMBI TEP), are equivalent or better than those of PET/ non enhanced CT scan (PET scan) associated with an enhanced CT scan. This research project is a pilot study given the few available data concerning this imaging exam reproducibility. This study allows us to assess the feasibility of such a large-scale study, but also to evaluate COMBI TEP performance. From these estimates, we can then consider a comparative study to evaluate the performance of COMBI PET.

This study is a prospective single center study.

Eligibility criteria: Inclusion Criteria:

Any patient with a cancerous disease for which PET scan is indicated in the SOR (Standards - Options - Recommendations) FDG PET 2003 updated in 2006 must be included in the trial, in the following locations:

1. Digestive cancers

   * Colorectal cancer

     * Preoperative evaluation in local and metastatic recurrence
     * Location of recurrences, in case of ACE increase in a previously operated patient.
   * Esophageal cancer: initial staging.
   * Pancreatic cancer

     * Initial staging,
     * Differential diagnosis with chronic pancreatitis.
   * Liver cancer: differential diagnosis of liver metastases, cholangiocarcinoma and benign tumors in the case of an isolated hepatic localization.
   * Digestive Endocrine tumors: staging in case of normal pentetreotide scintigraphy.
2. Lung cancer

   * Initial staging,
   * Diagnosis of lung isolated lesion \> 1 cm.
3. Head and neck cancer

   * Initial pretreatment staging,
   * Recurrence diagnosis
4. Lymphoma

   * Initial staging of Hodgkin's disease (HD), non-Hodgkin's lymphoma (NHL) and aggressive follicular lymphomas,
   * Diagnosis of minimal residual disease of HD and aggressive NHL,
   * Early assessment of treatment response.
5. Thyroid cancer: suspicion of residual disease or relapse when conventional imaging data are insufficient.
6. Ovarian cancer recurrence
7. Age ≥ 18 years.
8. Chest-abdomen-pelvis enhanced CT scan achieved within 4 weeks before enrollment (with cuts of less than 5 mm).
9. Woman of childbearing age with negative pregnancy test and / or contraception.
10. Patient with informed consent signed.
11. Patient affiliated to social security schemes.

Exclusion Criteria:

1. Iodine known allergy.
2. Diabetes, excepted if controlled (hemoglucotest ≤ 1.6 g).
3. Known renal failure (creatinine clearance \<60ml/min).
4. Indications against Xenetix ®:

   * Hypersensitivity to Xenetix ® or any of the excipients,
   * History of an immediate response or delayed cutaneous reaction to Xenetix ® injection.
   * Thyrotoxicosis.
5. Pregnant or lactating women.
6. Unable to undergo medical follow up for geographical, social or psychological reasons,
7. Private of freedom patient and adult under a legal guardianship or unable to consent.

Primary outcomes:
measure: Inter-observer (B1 and B2) Reproducibility of the PET-CT by Anatomical Regions
timeFrame: 1 year
Secondary outcomes:
measure: Inter-observer (B1 and B2) Reproducibility of the PET-CT at a Patient Level
timeFrame: 1 year
measure: Inter-observer (N1 and B2) Reproducibility of the PET-CT by Anatomical Regions
timeFrame: 1 year
measure: Inter-observer (N1 and B2) Reproducibility of the PET-CT at a Patient Level
timeFrame: 1 year
measure: Intra-observer Reproducibility of Injected CT Scan by Anatomical Regions
timeFrame: 1 year
measure: Intra-observer Reproducibility of Injected CT Scanat a Patient Level
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Institut Bergonié
name: CAZEAU Anne Laure, MD
role: STUDY_CHAIR
References: