Clinical Trials List
Protocol Number202501669A0
Not yet recruiting
2026-08-01 - 2031-08-31
Phase II
Not yet recruiting1
Cancer immunotherapy research targeting mismatch repair deficiency (dMMR): Multimodal integrated analysis combining hyperpolarized dynamic magnetic resonance (DNP) and artificial intelligence.
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Trial Applicant
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Sponsor
Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital
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Trial scale
Taiwan Single Center
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Update
2026/09/11
Investigators and Locations
Principal Investigator
Gigin Lin
Co-Principal Investigator
- Yun-Hsin Tang Division of Obstetrics & Gynecology
- Ting-Chang Chang Division of Obstetrics & Gynecology
- Angel Chao Division of Obstetrics & Gynecology
- 黃彥霖 Division of Others
- Feng-Yuan Liu Division of Nuclear Medicine
- 賴盈傑 Division of Radiology
- 張宸邠 Division of Obstetrics & Gynecology
- Chyong-Huey Lai Division of Obstetrics & Gynecology
- Chun-Chieh Wang Division of Radiation Therapy
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Newly diagnosed or recurrent gynecological cancers confirmed by histology, including ovarian cancer, cervical cancer, endometrial cancer and other gynecological cancers.
Objectives
By measuring immune activation and metabolic response to immune checkpoint inhibitor therapy in gynecological cancers using DNP-MRI, and combining retrospective imaging and medical record analysis, an artificial intelligence (AI) model was developed to predict the efficacy of cancer immune checkpoint inhibitor therapy targeting mismatch repair deficiency (dMMR).
Test Drug
Hyperpolarized [1-13C]Pyruvate
Active Ingredient
[1-13C]PYRUVIC ACID
Dosage Form
Intravenous infusion
Dosage
200 - 280 mM
Endpoints
(1) The ratio of 13C-lactic acid to 13C-pyruvate (Kpl value) of the spleen DNP-MRI at each scan time point was measured, and the dynamic conversion rate of 13C polarized metabolites was calculated to assess the efficacy of immune checkpoint inhibitor therapy.
(2) Clinical routine PET MRI/CT radiomics information was measured to assess the efficacy of immune checkpoint inhibitor therapy.
(2) Clinical routine PET MRI/CT radiomics information was measured to assess the efficacy of immune checkpoint inhibitor therapy.
Inclution Criteria
(1) Newly diagnosed or recurrent gynecological cancers confirmed by histology, including ovarian cancer, cervical cancer, endometrial cancer, and other gynecological cancers.
(2) Age ≥ 20 years.
(3) Patients who meet the criteria for immune checkpoint inhibitor therapy as assessed by their attending physician and who have been scheduled to receive immune checkpoint inhibitor therapy.
(2) Age ≥ 20 years.
(3) Patients who meet the criteria for immune checkpoint inhibitor therapy as assessed by their attending physician and who have been scheduled to receive immune checkpoint inhibitor therapy.
Exclusion Criteria
(1) Other malignant tumors (excluding non-melanoma skin cancer).
(2) History of splenic abnormalities (e.g., spleen damage, cirrhosis-related splenomegaly, or primary/metastatic splenic tumors).
(3) Bone marrow hematopoietic, hepatic, or renal insufficiency, defined as meeting any of the following criteria: Hb < 8 g/dL; ALT > 2.5 × ULN without liver metastases; ALT > 5 × ULN with liver metastases; or eGFR < 30 mL/min/1.73 m².
(4) Contraindications to MRI studies (e.g., claustrophobia, pacemaker, metal implants in the pelvis).
(5) Uncontrolled comorbidities, including but not limited to kidney stones, persistent or active infections, symptomatic heart failure, unstable angina, arrhythmias, or mental illness/social conditions that would limit compliance with study requirements.
(6) Known hypersensitivity to [1-¹³C]pyruvate and its derivatives and excipients. (7) Known allergy to [1-¹³C]pyruvate excipients.
(8) Pregnant or lactating women.
a. For patients with fertility potential, a pregnancy test will be performed during the screening phase and before the second DNP-MRI.
b. All female participants with fertility potential must agree to use at least one highly effective method of contraception for 7 days after the DNP-MRI, including:
I. Combined hormonal contraception containing estrogen and progesterone (oral, vaginal, or transdermal).
II. Hormonal contraception containing progesterone only (oral, injectable, or implantable).
III. Intrauterine device (IUD).
IV. Intrauterine hormone-releasing system (IUS).
V. Bilateral tubal occlusion.
VI. Abstinence (limited to the participant's consistent lifestyle).
VII. Sexual partners who have undergone vasectomy and have been confirmed to be azoospermic.
VIII. Sexual partners who use condoms and also use a second method of contraception (such as hormonal contraception or an IUD).
(9) Individuals who have received any immune checkpoint inhibitor treatment, including but not limited to anti-PD-1, anti-PD-L1, or anti-CTLA-4 medications.
(2) History of splenic abnormalities (e.g., spleen damage, cirrhosis-related splenomegaly, or primary/metastatic splenic tumors).
(3) Bone marrow hematopoietic, hepatic, or renal insufficiency, defined as meeting any of the following criteria: Hb < 8 g/dL; ALT > 2.5 × ULN without liver metastases; ALT > 5 × ULN with liver metastases; or eGFR < 30 mL/min/1.73 m².
(4) Contraindications to MRI studies (e.g., claustrophobia, pacemaker, metal implants in the pelvis).
(5) Uncontrolled comorbidities, including but not limited to kidney stones, persistent or active infections, symptomatic heart failure, unstable angina, arrhythmias, or mental illness/social conditions that would limit compliance with study requirements.
(6) Known hypersensitivity to [1-¹³C]pyruvate and its derivatives and excipients. (7) Known allergy to [1-¹³C]pyruvate excipients.
(8) Pregnant or lactating women.
a. For patients with fertility potential, a pregnancy test will be performed during the screening phase and before the second DNP-MRI.
b. All female participants with fertility potential must agree to use at least one highly effective method of contraception for 7 days after the DNP-MRI, including:
I. Combined hormonal contraception containing estrogen and progesterone (oral, vaginal, or transdermal).
II. Hormonal contraception containing progesterone only (oral, injectable, or implantable).
III. Intrauterine device (IUD).
IV. Intrauterine hormone-releasing system (IUS).
V. Bilateral tubal occlusion.
VI. Abstinence (limited to the participant's consistent lifestyle).
VII. Sexual partners who have undergone vasectomy and have been confirmed to be azoospermic.
VIII. Sexual partners who use condoms and also use a second method of contraception (such as hormonal contraception or an IUD).
(9) Individuals who have received any immune checkpoint inhibitor treatment, including but not limited to anti-PD-1, anti-PD-L1, or anti-CTLA-4 medications.
The Estimated Number of Participants
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Taiwan
30 participants
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Global
30 participants
