Cancer Disease Progression Clinical Trial
— COMBITEPOfficial title:
PET / Enhanced CT Scan Performance in Cancer (Positron Emission Tomography Combined With Computed Tomography or Vascular Contrast CT Scan). COMBI TEP Study
| NCT number | NCT01881620 |
| Other study ID # | IB2009-70 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 19, 2010 |
| Est. completion date | July 15, 2015 |
| Verified date | July 2019 |
| Source | Institut Bergonié |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 109 |
| Est. completion date | July 15, 2015 |
| Est. primary completion date | July 19, 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Institut Bergonié |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |