PET Enhanced CT Scan Performance in Cancer

NCT ID: NCT01881620

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-19
• Study Completion Date: 2015-07-15

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.

Conditions

Cancer Disease Progression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

COMBI TEP : PET / enhanced CT scan

COMBI TEP : PET / enhanced CT scan

Group Type: EXPERIMENTAL

COMBI TEP : PET / enhanced CT scan

Intervention Type: DEVICE

diagnostic imaging exam

Interventions

COMBI TEP : PET / enhanced CT scan

diagnostic imaging exam

Intervention Type: DEVICE

Other Intervention Names

diagnostic imaging exam

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Bergonié

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

CAZEAU Anne Laure, MD

Role: STUDY_CHAIR

Institut Bergonié

Related Links

https://www.bergonie.fr/les-essais-cliniques/

Site internet du promoteur, l'Institut Bergonié

Other Identifiers

IB2009-70

Identifier Type: -

Identifier Source: org_study_id