PET Enhanced CT Scan Performance in Cancer (COMBITEP)

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer Disease Progression
• Intervention / Treatment: Device: COMBI TEP : PET / enhanced CT scan

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.

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COMBI TEP : PET / enhanced CT scan	Device: COMBI TEP : PET / enhanced CT scan; diagnostic imaging exam; Other Names: diagnostic imaging exam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter-observer (B1 and B2) Reproducibility of the PET-CT by Anatomical Regions	The primary endpoint was the inter-observer reproducibility of the interpretation of the combined PET / enhanced CT scan (PET-CT) by anatomical region. Reproducibility was assessed for each of the 5 anatomical regions (thorax, abdomen, pelvis, bone, nervous system). Two independant pairs (B1 and B2), each composed of one nuclear physician and one radiologist interpreted the PET-CT examination and described each of the 5 anatomical régions according to 3 modalities (Presence of suspicious lesion(s); Presence of dubious lesion(s); Absence of suspicious and dubious lesion). The inter-observer reproducibility (inter-pairs of observers) was evaluated for each anatomical region by comparing the interpretations of the two pairs, using the weighted kappa concordance coefficient [ref = Fleiss J, Levin B, Cho Paik M. Statistical methods for rates and proportions. Third ed. 2003.].Interpretation by B1 after PET-CT examination (1 month after). Interpretation by B2 at the end of the study	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter-observer (B1 and B2) Reproducibility of the PET-CT at a Patient Level	The inter-observer reproducibility of combined PET-CT interpretations has been assessed globally for each patient. Same pairs of observer (B1 and B2) than for the primary endpoint evaluation interpreted the PET-CT examination in a global way and concluded for each patient. A weighted Kappa coefficient has been calculated from an identical methodology to that described for the primary endpoint evaluation. Interpretation by B1 was performed at least 1 month and 1 week after PET-CT examination. Interpretation by B2 was performed at the end of the study	1 year
Inter-observer (N1 and B2) Reproducibility of the PET-CT by Anatomical Regions	For each of the 5 anatomical régions (thorax, abdomen, pelvis, bone, nervous system), we evaluated the reproducibility between the interpretations of the PET-CT by the nuclear physician alone (N1) and the independent pair (B2) composed by one nuclear physician and one radiologist . The nuclear physician alone (N1) and the independent pair (B2) interpreted the PET-CT examination independently and described each anatomical region.The inter-observer reproducibility has been evaluated for each anatomical region by comparing the interpretations of the nuclear physician alone and that one of independent pair of nuclear physician and radiologist, using the weighted kappa concordance coefficient [ref = Fleiss J, Levin B, Cho Paik M. Statistical methods for rates and proportions. Third ed. 2003.].Interpretation by nuclear physician alone (N1) was performed within 1 week of PET-CT examination. Interpretation by B2 was performed at the end of the study	1 year
Inter-observer (N1 and B2) Reproducibility of the PET-CT at a Patient Level	The inter-observer reproducibility of combined PET-CT interpretations has been assessed globally for each patient. The nuclear physician alone (N1) and the independent pair (B2) interpreted the PET-CT examination independently in a global way and concluded for each patient. The inter-observer reproducibility has been evaluated at patient level by comparing the interpretations of the nuclear physician alone and that one of independent pair of nuclear physician and radiologist, using the weighted kappa concordance coefficient [ref = Fleiss J, Levin B, Cho Paik M. Statistical methods for rates and proportions. Third ed. 2003.]. Interpretation by nuclear physician alone (N1) was performed within 1 week of PET-CT examination. Interpretation by B2 was performed at the end of the study	1 year
Intra-observer Reproducibility of Injected CT Scan by Anatomical Regions	For each anatomical region, the reproducibility of the injected CT scan was evaluated. The same radiologist evaluated the two injected CT scans (CT1 and CT2) and interpreted them (Presence of suspicious lesion(s) OR presence of dubious lesion(s) OR absence of suspicious and dubious lesion). Intra-observer reproducibility was analyzed by using the individual analysis by each radiologist. A weighted Kappa concordance coefficient was calculated per anatomical region using a methodology identical to that described for the evaluation of the proncipal endpoint. Interpretation of CT1 was performed befor inclusion. Interpretation of CT2 was performed at the end of the study.	1 year
Intra-observer Reproducibility of Injected CT Scanat a Patient Level	The reproducibility of the injected CT scan was evaluated globally for each patient. The same radiologist evaluated the two injected CT scans (CT1 and CT2) and interpreted them (Presence of suspicious lesion(s) OR presence of dubious lesion(s) OR absence of suspicious and dubious lesion). Intra-observer reproducibility was analyzed by using the individual analysis by each radiologist. A weighted Kappa concordance coefficient was calculated using a methodology identical to that described for the evaluation of the proncipal endpoint. Interpretation of CT1 was performed befor inclusion. Interpretation of CT2 was performed at the end of the study.	1 year

Collaborators and Investigators

• Sponsor: Institut Bergonié
• Investigators: Study Chair: CAZEAU Anne Laure, MD, Institut Bergonie

Publications and helpful links

Helpful Links

• Site internet du promoteur, l'Institut Bergonié

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2010
• Primary Completion (Actual): July 19, 2012
• Study Completion (Actual): July 15, 2015

Study Registration Dates

• First Submitted: November 5, 2012
• First Submitted That Met QC Criteria: June 17, 2013
• First Posted (Estimated): June 19, 2013

Study Record Updates

• Last Update Posted (Actual): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: PET scan; CT scan; Diagnostic performance
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Progression
• Other Study ID Numbers: IB2009-70