Clinical Trials List
Protocol NumberMOST 109-2628-B-182A-007-, MOST 110-2628-B-182A-004-, MOST 111-2628-B-182A-001-
NCT Number(ClinicalTrials.gov Identfier)NCT04951921
2021-03-01 - 2023-07-31
Phase II
Recruiting1
Precision Medicine Imaging for Cervical Cancer: Integrating MR Fingerprinting, Dynamic Nuclear Polarization (DNP)-MRI and Artificial Intelligence Radiomics
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Sponsor
Chang Gung Memorial Hospital
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Trial scale
Taiwan Single Center
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Update
2023/03/10
Investigators and Locations
Co-Principal Investigator
- Chun-Chieh Wang Division of Radiation Therapy
- Chyong-Huey Lai Division of Obstetrics & Gynecology
- Feng-Yuan Liu Division of Nuclear Medicine
- 林育駿放射師 Division of Radiology
- 謝憬儀 未分科
- Tzu-Chen Yen Division of Nuclear Medicine
- 楊嵐燕 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Cervical Cancer
Objectives
Develop a clinical trial to validate DNP MRI for LACC, early detect poor responders
to CCRT, based on a 3-year clinical trial with non-randomized, single group assignment and
observational study design. Thirty participants with newly diagnosed LACC, FIGO stage IB2-IVA,
screened by staging MRI/CT planned for CCRT will be recruited. A tumor biopsy and routine blood
test will be obtained at the time of the initial clinic visit. Participants eligible for this study will receive
two investigative DNP MRI exams, with blood and urine metabolomics analysis: baseline and 2-
week during CCRT.
Test Drug
Hyperpolarized [1-13C]Pyruvate
Active Ingredient
[1-13C]Pyruvic acid
Dosage Form
Injection
Dosage
~250
Endpoints
1. 測量DNP-MRI之13C-乳酸與13C-丙酮酸比值 (Kpl值)。
2. 以MRI測量完整CCRT後之腫瘤大小。
3. 持續追蹤病患臨床預後表徵，結合DNP-MRI與MRF/CEST/DWI等資料，推估與復發機率及存活率之關聯性。
2. 以MRI測量完整CCRT後之腫瘤大小。
3. 持續追蹤病患臨床預後表徵，結合DNP-MRI與MRF/CEST/DWI等資料，推估與復發機率及存活率之關聯性。
Inclution Criteria
1. Histologically confirmed squamous cell carcinoma or adenocarcinoma or adenosquamous
carcinoma of the uterine cervix.
2. Age ≥ 20 years.
3. Clinical International Federation of Gynecology and Obstetrics (FIGO) stage IB2-IVA
4. Tumor diameter ≥ 4 cm verified by magnetic resonance image (MRI) or computed
tomography (CT).
5. Curative-intent treatment with cisplatin-based concurrent chemoradiotherapy.
carcinoma of the uterine cervix.
2. Age ≥ 20 years.
3. Clinical International Federation of Gynecology and Obstetrics (FIGO) stage IB2-IVA
4. Tumor diameter ≥ 4 cm verified by magnetic resonance image (MRI) or computed
tomography (CT).
5. Curative-intent treatment with cisplatin-based concurrent chemoradiotherapy.
Exclusion Criteria
1. Concurrent or history of malignant tumor(s) other than treated non-melanoma skin cancer
2. Had received surgical or cytotoxic procedure including chemotherapy, radiotherapy or
therapy with biologic response modifier(s) for the cervical tumor
3. Other cervical cancer tumor histologies (e.g. small cell, serous)
4. Contraindication to MRI study (e.g. claustrophobia, cardiac pacemaker, metal implants in
pelvis)
5. Inadequate marrow, liver and renal functions
6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection,
symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or
psychiatric illness/social situations that would limit compliance with study requirements
7. Pregnant or breast feeding women
2. Had received surgical or cytotoxic procedure including chemotherapy, radiotherapy or
therapy with biologic response modifier(s) for the cervical tumor
3. Other cervical cancer tumor histologies (e.g. small cell, serous)
4. Contraindication to MRI study (e.g. claustrophobia, cardiac pacemaker, metal implants in
pelvis)
5. Inadequate marrow, liver and renal functions
6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection,
symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or
psychiatric illness/social situations that would limit compliance with study requirements
7. Pregnant or breast feeding women
The Estimated Number of Participants
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Taiwan
30 participants
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Global
30 participants
