NCT06142760Recruiting
MR-guidance in Chemoradiotherapy for Cervical Cancer
Daily AI-based Treatment Adaptation Under Weekly Offline MR-guidance in Chemoradiotherapy for Cervical Cancer 1 AIM-C1
Source: ClinicalTrials.gov · Last updated 9 Mar 2026
Brief summary (registry, in English)
Concurrent chemoradiotherapy (CCRT), consisting of external beam radiotherapy (EBRT) and chemotherapy, followed by brachytherapy (BT) is the standard of care for patients with locally advanced cervical carcinoma. In current clinical practice, conventionally, one radiotherapy plan based on the initial planning computed tomography (CT) and magnetic resonance imaging (MRI) scan of the pelvis is applied for the complete 5-6 weeks of EBRT. However, there is a high degree of cervix and uterus motion in the pelvis due to different fillings of the bladder and the bowel. Consequently, large safety margins are required to compensate for organ movement, potentially leading to higher toxicity. Lately, daily high-quality cone-beam CT (CBCT) guided adaptive radiotherapy, aided by artificial intelligence (AI), became clinically available. Due to the improved soft-tissue contrast, the treatment plan can now be online adapted to the current position of the tumor and the adjacent organs-at-risk (OAR), while the patient is lying on the treatment couch. Moreover, the German Research Cancer Center offers the unique possibility of additional weekly magnetic resonance imaging (MRI) in treatment position using a shuttle system. Daily CBCT-adapted EBRT in combination with weekly MRI in treatment position might therefore offer superior sparing of surrounding OAR and consequently reduction of treatment-associated side-effects. However, to the investigators knowledge, no toxicity data for daily CBCT/AI adaptive EBRT of locally advanced cervical cancer with additional MR-guidance exists. The AIM-C1 trial therefore aims to assess the potential of daily CBCT adaptive and AI aided EBRT combined with additional weekly offline MR-guidance in treatment position using a shuttle system.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 15 Nov 2023
- Start date
- 15 Nov 2023
- Primary completion date
- 1 Nov 2026
- Lead sponsor
- Juergen Debus
- Diseases
- Cervical cancer
- NCT number
- NCT06142760
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 15 Nov 2023 to the primary completion date, 1 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous radiotherapy of the pelvic region
- previous total or partial hysterectomy
- neoadjuvant chemotherapy
Other illness
- small cell neuroendocrine cancer, melanoma and other rare cancers of the cervix
- contraindications against performing contrast-enhanced MRI scans (pacemakers, other implants making MRI impossible, allergy to gadolinium (GD)-based contrast agent)
- other primary malignancies within 5 years before except carcinoma in situ of the cervix and basal cell carcinoma of the skin
Other
- FIGO stage IIIC2 and IV
- Paraaortic lymphatic node metastases
- claustrophobia
- pregnant or lactating women
- patient is enrolled in another study, that could influence the outcome of the presented study
Who the study is looking for
- biopsy-proven cervical cancer including squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma
- FIGO stage IB, IIA, IIB, IIIA, IIIB, IIIC1
- indication and eligibility for definitive chemoradiotherapy including brachytherapy discussed in an interdisciplinary tumor board
- Karnofsky performance score ≥ 70%
- 18-80 years of age
- Capacity of the patient to consent to participation in the study
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of Heidelberg, Radiation Oncology Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.