PET Enhanced CT Scan Performance in Cancer (COMBITEP)

Institut Bergonié

Status: Completed

Conditions: Cancer Disease Progression

Treatments: Device: COMBI TEP : PET / enhanced CT scan

Study type: Interventional

Funder types: Other

Identifiers

NCT01881620

IB2009-70

Details and patient eligibility

About

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.

Full 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.

Enrollment: 109 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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109 participants in 1 patient group

COMBI TEP : PET / enhanced CT scan

Experimental group

Description:

COMBI TEP : PET / enhanced CT scan

Treatment:

Device: COMBI TEP : PET / enhanced CT scan