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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


N/A
18 Years
N/A
Not Enrolling
Both
Cancer Disease Progression

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

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:

No

Principal Investigator

CAZEAU Anne Laure, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Institut Bergonié

Authority:

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

Study ID:

IB2009-70

NCT ID:

NCT01881620

Start Date:

March 2010

Completion Date:

May 2012

Related Keywords:

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

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