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PET / Enhanced CT Scan Performance in Cancer (Positron Emission Tomography Combined With Computed Tomography or Vascular Contrast CT Scan). COMBI TEP Study

18 Years
Not Enrolling
Cancer Disease Progression

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Trial Information

PET / Enhanced CT Scan Performance in Cancer (Positron Emission Tomography Combined With Computed Tomography or Vascular Contrast CT Scan). COMBI TEP Study


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.

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

- 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

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 ®

- Thyrotoxicosis.

5. Pregnant or lactating women.

6. Unable to undergo medical follow up for geographical, social or psychological

7. Private of freedom patient and adult under a legal guardianship or unable to consent.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Diagnostic performance of the combination PET / enhanced CT scan (COMBI PET)

Outcome Description:

Performance will be evaluated in terms of the inter-pairs interpretation reproducibility, one pair being defined by the combination of one nuclear physician and one radiologist.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

CAZEAU Anne Laure, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Institut Bergonié


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

March 2010

Completion Date:

May 2012

Related Keywords:

  • Cancer Disease Progression
  • PET scan
  • CT scan
  • Diagnostic performance
  • Disease Progression