Clinical trial · Interventional
PET/MRI Scan for the Evaluation of Resectable Stage IA1-IB3 Cervical Cancer
Evaluation of Resectable Cervical Carcinoma With PET/MRI
NCT04219904CI-TRIAL-00112137active not recruitingEarly Phase 1ClinicalTrials.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)
This trial studies how well positron emission tomography/magnetic resonance imaging (PET/MRI) scan works in checking patients with stage IA1-IB3 cervical cancer that can be removed by surgery (resectable). PET/MRI scan may help doctors learn more about the spread of the disease.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IA1 Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IA2 Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IA Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB1 Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB2 Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB3 Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fludeoxyglucose F-18 | Other | — | UNRESOLVED |
| Gadobutrol | Drug | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (PET/MRI)
- description
- Patients receive fludeoxyglucose F-18 and gadobutrol IV over 1 minute and undergo PET/MRI over 90-120 minutes.
- interventionNames
- Other: Fludeoxyglucose F-18
- Drug: Gadobutrol
- Procedure: Magnetic Resonance Imaging
- Procedure: Positron Emission Tomography
Primary outcomes (1)
- measure
- Accuracy of diagnosing depth of invasion on positron emission tomography/magnetic resonance imaging (PET/MRI)
- timeFrame
- 3 years
- description
- Both PET/MRI and pathology results will be dichotomized into binary outcomes and the accuracy of PET/MRI will assessed.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All patients with suspected clinical stage IA1-IB3 cervical cancer except patients with tumors \> 4 cm * No contraindications to MRI * Patients undergoing surgical procedure at MD Anderson * Suspected cervical cancer Exclusion Criteria: * Patients who have contraindication to MRI * Glomerular filtration rate (GFR) \< 30 * Pregnant patients * Patients with history of previous radiation * Patients with previous surgery for cervical cancer, unless residual tumor noted on physical exam * Patients with endometrial cancer extending to the cervix * Allergic reaction to gadolinium based contrast * Body weight of greater than 450 (181.4 kg) * Patients requiring general sedation * Extremely claustrophobic patients
References
Publications (0)
Data not yet available
No reference posted for this study.