Clinical trial · Interventional
Impact of Positron Emission Tomography (PET) Imaging in Women With Locally Advanced Cervical Cancer (PET LACE Trial)
The Impact of Positron Emission Tomography (PET) Imaging in Women With Locally Advanced Cervical Cancer
- 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)
The purpose of this trial is to improve the clinical management and outcome of patients with locally advanced cervical cancer by using positron emission tomography-computed tomography (PET-CT) imaging. There is considerable debate worldwide regarding the utility of PET for staging cervical cancer. Although there are studies on the accuracy (sensitivity and specificity) of PET in cervical cancer, there are currently no prospective randomized studies on how PET information affects treatment decisions and outcomes.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Adenosquamous Carcinoma | Adenosquamous Carcinoma | ONTOLOGY_EXACT | 0.90 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CT Abdomen and Pelvis scan | Procedure | — | UNRESOLVED |
| CT Abdomen and Pelvis scan + whole body PET-CT scan | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- CT Abdomen and Pelvis + whole body PET-CT
- interventionNames
- Procedure: CT Abdomen and Pelvis scan + whole body PET-CT scan
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- CT Abdomen and Pelvis
- interventionNames
- Procedure: CT Abdomen and Pelvis scan
Primary outcomes (1)
- measure
- Treatment delivered between patients having whole body 18FDG PET-CT in addition to CT of the abdomen and pelvis versus patients having a CT of the abdomen and pelvis alone.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women with newly diagnosed histologically confirmed FIGO Stage IB-IVA carcinoma of the cervix, including squamous, adenosquamous or adenocarcinoma. Women not suitable for surgery due to comorbidities (medical or other conditions) are also considered eligible. * Age equal to or greater than 18 years * Being considered for treatment with curative intent using concurrent chemotherapy and pelvic RT. Exclusion Criteria: * ECOG performance status greater than 2. * Other cervical cancer tumour types (e.g. neuroendocrine, serous). * Carcinoma of the cervical stump. * Prior hysterectomy. * Patients who, at the time of the initial evaluation, have already undergone a whole body PET-CT within the last 6 months. * Contraindications to 18FDG PET-CT or CT of the abdomen and pelvis. * Inability to lie supine for imaging with PET-CT. * Contraindication to radiotherapy (i.e., significant Crohn's disease). * Contraindication to cisplatin chemotherapy (i.e., non-reversible renal failure). * Inadequate bone marrow function: ANC less than 1.5 X 10\^9, platelets less than 100 X 10\^9. * Inadequate renal function: Creatinine greater/equal to 150 micromol/L * Inadequate hepatic function: Bilirubin greater than 1.5 X ULN and SGOT and Alkaline Phosphatase greater than 3 X ULN. * History of another invasive malignancy within the previous 5 years with the exception of non-melanoma skin cancer. * Other medical conditions that may preclude chemo-radiation therapy. * Known pregnancy or lactating. * Inability to complete study or required follow-up.
References
Publications (1)
- DERIVEDElit LM, Fyles AW, Gu CS, Pond GR, D'Souza D, Samant R, Anthes M, Thomas G, Filion M, Arsenault J, Dayes I, Whelan TJ, Gulenchyn KY, Metser U, Dhamanaskar K, Levine MN. Effect of Positron Emission Tomography Imaging in Women With Locally Advanced Cervical Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2018 Sep 7;1(5):e182081. doi: 10.1001/jamanetworkopen.2018.2081. PMID 30646153