Clinical Trials List
Protocol Number202301898A0
Active
2025-10-01 - 2027-07-31
Phase II
Recruiting1
ICD-10C20
Malignant neoplasm of rectum
ICD-10C7A.026
Malignant carcinoid tumor of the rectum
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9154.1
Malignant neoplasm of rectum
Integrating precision imaging technologies for rectal cancer patients receiving pre-treatment radiochemotherapy: hyperpolarized carbon-13 magnetic resonance imaging, metabolomics, and radiomics.
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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
2026/07/13
Investigators and Locations
Condition/Disease
rectal cancer
Objectives
This program will integrate precision imaging technology to provide immediate and accurate efficacy predictions for rectal cancer patients undergoing pre-treatment radiochemotherapy. It will also establish more precise prognostic risk stratification to provide more accurate clinical treatment guidance for patients. This will improve patients' clinical outcomes and treatment-related quality of life, while saving unnecessary treatment and examination costs.
Test Drug
Hyperpolarized [1-13C]Pyruvate
Active Ingredient
PYRUVIC ACID
Dosage Form
Intravenous infusion
Dosage
200 - 280 mM
Endpoints
This study investigates the predictive potential of metabolic changes in rectal cancer patients who have achieved complete clinical remission following pre-treatment radiochemotherapy.
Inclution Criteria
1. Patient diagnosed with rectal cancer via biopsy.
2. To be receiving pre-treatment radiochemoradiotherapy (nCRT).
3. Age 18 years or older.
2. To be receiving pre-treatment radiochemoradiotherapy (nCRT).
3. Age 18 years or older.
Exclusion Criteria
(1) Pregnant or lactating women.
a. For patients with childbearing potential, a pregnancy test will be performed before the screening stage and the second hyperpolarized 13C-MRI.
b. All female participants of childbearing potential must agree to use at least one highly effective contraceptive method within 7 days after undergoing hyperpolarized 13C-MRI, including:
I. Combined hormonal contraceptive methods (oral, intravaginal, or transdermal) containing estrogen and progesterone.
II. Progestin-only hormonal contraceptive methods (oral, injectable or implantable).
III. Intrauterine device (IUD).
IV. Intrauterine hormone system (IUS).
V. Bilateral fallopian tube occlusion.
VI. Abstinence (limited to the lifestyle that the participant has always maintained).
VII. Sexual partners who have undergone vasectomy and are confirmed to have no sperm.
VIII. Sexual partners who use condoms in conjunction with a second method of contraception (such as a hormonal method or IUD).
(2) Conditions that are not suitable for magnetic resonance imaging, such as strong magnetic arterial clamps in the brain, pacemakers and cochlear implants, and claustrophobia.
(3) Comorbidities that would affect the patient during the MRI examination (e.g., active infection, symptomatic congestive heart failure, uncontrolled angina, cardiac arrhythmia, mental disorder, dyspnea, or diarrhea).
(4) Severe liver function abnormalities (alkaline phosphatase (ALP)/aspartate aminotransferase (AST)/alanine aminotransferase (ALT) exceeds 3 times the upper limit of normal [ULN], or bilirubin exceeds 2 times the upper limit of normal).
(5) Severe renal dysfunction (estimated glomerular filtration rate eGFR < 30 ml/min/1.73m²).
(6) Known hypersensitivity to [1-¹³C]pyruvic acid and its derivatives.
(7) Known hypersensitivity to [1-¹³C]pyruvate excipient.
a. For patients with childbearing potential, a pregnancy test will be performed before the screening stage and the second hyperpolarized 13C-MRI.
b. All female participants of childbearing potential must agree to use at least one highly effective contraceptive method within 7 days after undergoing hyperpolarized 13C-MRI, including:
I. Combined hormonal contraceptive methods (oral, intravaginal, or transdermal) containing estrogen and progesterone.
II. Progestin-only hormonal contraceptive methods (oral, injectable or implantable).
III. Intrauterine device (IUD).
IV. Intrauterine hormone system (IUS).
V. Bilateral fallopian tube occlusion.
VI. Abstinence (limited to the lifestyle that the participant has always maintained).
VII. Sexual partners who have undergone vasectomy and are confirmed to have no sperm.
VIII. Sexual partners who use condoms in conjunction with a second method of contraception (such as a hormonal method or IUD).
(2) Conditions that are not suitable for magnetic resonance imaging, such as strong magnetic arterial clamps in the brain, pacemakers and cochlear implants, and claustrophobia.
(3) Comorbidities that would affect the patient during the MRI examination (e.g., active infection, symptomatic congestive heart failure, uncontrolled angina, cardiac arrhythmia, mental disorder, dyspnea, or diarrhea).
(4) Severe liver function abnormalities (alkaline phosphatase (ALP)/aspartate aminotransferase (AST)/alanine aminotransferase (ALT) exceeds 3 times the upper limit of normal [ULN], or bilirubin exceeds 2 times the upper limit of normal).
(5) Severe renal dysfunction (estimated glomerular filtration rate eGFR < 30 ml/min/1.73m²).
(6) Known hypersensitivity to [1-¹³C]pyruvic acid and its derivatives.
(7) Known hypersensitivity to [1-¹³C]pyruvate excipient.
The Estimated Number of Participants
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Taiwan
30 participants
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Global
30 participants
