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PET Enhanced CT Scan Performance in Cancer (COMBITEP)

I

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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