Clinical trial · Interventional
PET Enhanced CT Scan Performance in Cancer
PET / Enhanced CT Scan Performance in Cancer (Positron Emission Tomography Combined With Computed Tomography or Vascular Contrast CT Scan). COMBI TEP Study
NCT01881620CI-TRIAL-00082615COMBITEPcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Disease Progression | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| COMBI TEP : PET / enhanced CT scan | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- COMBI TEP : PET / enhanced CT scan
- description
- COMBI TEP : PET / enhanced CT scan
- interventionNames
- Device: COMBI TEP : PET / enhanced CT scan
Primary outcomes (1)
- measure
- Inter-observer (B1 and B2) Reproducibility of the PET-CT by Anatomical Regions
- timeFrame
- 1 year
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.References
Publications (0)
Data not yet available
No reference posted for this study.