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PET Enhanced CT Scan Performance in Cancer (COMBITEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01881620
Recruitment Status : Completed
First Posted : June 19, 2013
Results First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Bergonié

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.


Condition or disease Intervention/treatment Phase
Cancer Disease Progression Device: COMBI TEP : PET / enhanced CT scan Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PET / Enhanced CT Scan Performance in Cancer (Positron Emission Tomography Combined With Computed Tomography or Vascular Contrast CT Scan). COMBI TEP Study
Actual Study Start Date : March 19, 2010
Actual Primary Completion Date : July 19, 2012
Actual Study Completion Date : July 15, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: COMBI TEP : PET / enhanced CT scan
COMBI TEP : PET / enhanced CT scan
Device: COMBI TEP : PET / enhanced CT scan
diagnostic imaging exam
Other Name: diagnostic imaging exam




Primary Outcome Measures :
  1. Inter-observer (B1 and B2) Reproducibility of the PET-CT by Anatomical Regions [ Time Frame: 1 year ]
    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


Secondary Outcome Measures :
  1. Inter-observer (B1 and B2) Reproducibility of the PET-CT at a Patient Level [ Time Frame: 1 year ]
    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

  2. Inter-observer (N1 and B2) Reproducibility of the PET-CT by Anatomical Regions [ Time Frame: 1 year ]
    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

  3. Inter-observer (N1 and B2) Reproducibility of the PET-CT at a Patient Level [ Time Frame: 1 year ]
    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

  4. Intra-observer Reproducibility of Injected CT Scan by Anatomical Regions [ Time Frame: 1 year ]
    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.

  5. Intra-observer Reproducibility of Injected CT Scanat a Patient Level [ Time Frame: 1 year ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881620


Sponsors and Collaborators
Institut Bergonié
Investigators
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Study Chair: CAZEAU Anne Laure, MD Institut Bergonié

Additional Information:
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Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT01881620    
Other Study ID Numbers: IB2009-70
First Posted: June 19, 2013    Key Record Dates
Results First Posted: October 1, 2019
Last Update Posted: October 1, 2019
Last Verified: July 2019
Keywords provided by Institut Bergonié:
PET scan
CT scan
Diagnostic performance
Additional relevant MeSH terms:
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Disease Progression
Disease Attributes
Pathologic Processes