Clinical trial · Interventional
Hyperpolarized 13C MR Imaging of Lactate in Patients With Locally Advanced Cervical Cancer (LACC) Cervical Cancer
Hyperpolarized 13C MR Imaging of Lactate in Patients With Locally Advanced Cervical Cancer for Treatment With Definitive Chemoradiation Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of participants
Summary
Brief summary (as posted)
The purpose of this study is to image tumour lactate in study participants with locally advanced cervical cancer. Our hypothesis is that lactate content in cervical tumours, as measured by hyperpolarized 13C Magnetic Resonance (MR) imaging, will correlate with diffusion-weighted MRI and 18FDG-PET (fluorodeoxyglucose-positron emission tomography). Furthermore, lactate imaging will potentially provide additional and more specific information regarding the metabolic activity of cervical tumours, thereby identifying regions of radiation resistance and guiding radiation treatment and brachytherapy.
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 |
|---|---|---|---|
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FDG | Drug | — | UNRESOLVED |
| Hyperpolarized 13C-Pyruvate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Hyperpolarized Pyruvate (13C) Injection
- description
- Participants will be injected with the study drug Hyperpolarized Pyruvate (13C) Injection at a dose of 0.43 ml/kg and will have their cervix imaged using MRI.
- interventionNames
- Drug: Hyperpolarized 13C-Pyruvate
- type
- ACTIVE_COMPARATOR
- label
- 18F-FDG
- description
- Participants will be injected with the study drug 18F-FDG at a dose of 5 MBq/kg to a a maximum of 500 MBq (megabecquerel) and will have their cervix imaged using PET-CT imaging.
- interventionNames
- Drug: 18F-FDG
Primary outcomes (1)
- measure
- Time resolved, 3D 13C lactate images from subjects with cervical cancer.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix, International Federation of Gynecology and Obstetrics (FIGO) stage IB-IVA * Planned treatment with radical radiotherapy with or without concurrent cisplatin chemotherapy. * Age ≥ 18 years. Exclusion Criteria: * Any anticancer treatment for their cervical cancer. * Eastern Cooperative Oncology Group (ECOG) performance status \> 2 * Other cervical cancer tumor histologies (e.g. small cell, serous) * Contraindications to 18FDG PET-CT * Inability to lie supine for 18FDG PET-CT * Contraindication to radiotherapy (e.g. severe Crohn's disease) * History of another invasive malignancy, except for non-melanoma skin cancer or tumors curatively treated with no evidence of disease for ≥ 5 years. * Known pregnancy or lactating
References
Publications (0)
Data not yet available