Stage IB Cervical Cancer Clinical Trial
Official title:
Evaluation of Resectable Cervical Carcinoma With PET/MRI
Verified date | May 2024 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This trial studies how well positron emission tomography/magnetic resonance imaging (PET/MRI) scan works in checking patients with stage IA1-IB3 cervical cancer that can be removed by surgery (resectable). PET/MRI scan may help doctors learn more about the spread of the disease.
Status | Active, not recruiting |
Enrollment | 25 |
Est. completion date | September 30, 2025 |
Est. primary completion date | September 30, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All patients with suspected clinical stage IA1-IB3 cervical cancer except patients with tumors > 4 cm - No contraindications to MRI - Patients undergoing surgical procedure at MD Anderson - Suspected cervical cancer Exclusion Criteria: - Patients who have contraindication to MRI - Glomerular filtration rate (GFR) < 30 - Pregnant patients - Patients with history of previous radiation - Patients with previous surgery for cervical cancer, unless residual tumor noted on physical exam - Patients with endometrial cancer extending to the cervix - Allergic reaction to gadolinium based contrast - Body weight of greater than 450 (181.4 kg) - Patients requiring general sedation - Extremely claustrophobic patients |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy of diagnosing depth of invasion on positron emission tomography/magnetic resonance imaging (PET/MRI) | Both PET/MRI and pathology results will be dichotomized into binary outcomes and the accuracy of PET/MRI will assessed. | 3 years | |
Secondary | Assessing the Lymph node involvement by PET/MRI | Will determine the relationship with pathology. | 3 years | |
Secondary | Inter-observer variability of PET/MR | A PET report for clinical use will be generated by a radiologist with appropriate training and credentialing to read PET images. A separate MRI report for clinical use will be generated by a radiologist with appropriate training and credentialing to read MRI. Subsequently, PET/MR images will be evaluated by two radiologists who have appropriate training to read both PET and MRI and 2 research reports will be generated. Inter-observer variability of PET/MRI will be calculated using Cohen's kappa coefficient. | 3 years | |
Secondary | Quantitative imaging parameters of the tumor | Correlate the quantitative imaging parameters of the tumor, such as the volumetric size, blood oxygen level-dependent (BOLD), apparent diffusion coefficient (ADC), IVIM analysis, diffusion tensor imaging (DTI), dynamic contrast-enhanced (DCE), MTV, TLG, standardized uptake value (SUV) and GMR with LVSI and tumor grade on surgical pathology which serves as gold standard. Two-sample t-test or analysis of variance (ANOVA) will be used for comparing the group means between LVSI positive/negative groups and among tumor grades and types. Other statistical analysis will be carried out as appropriate. | 3 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Suspended |
NCT01958658 -
AZD1775, Cisplatin, and Radiation Therapy in Treating Patients With Cervical Cancer
|
Phase 1 | |
Completed |
NCT00416455 -
Fludeoxyglucose (FDG) F 18 PET Scan, CT Scan, and Ferumoxtran-10 MRI Scan Before Chemotherapy and Radiation Therapy in Finding Lymph Node Metastasis in Patients With Locally Advanced Cervical Cancer or High-Risk Endometrial Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT00054444 -
Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer
|
Phase 1 | |
Completed |
NCT01764802 -
Psychosexual Intervention in Patients With Stage I-III Gynecologic or Breast Cancer
|
Phase 2 | |
Completed |
NCT00068549 -
Radiation Therapy Plus Cisplatin and Gemcitabine in Treating Patients With Cervical Cancer
|
Phase 1 | |
Completed |
NCT00559377 -
FDG and FMISO PET Hypoxia Evaluation in Cervical Cancer
|
Phase 2 | |
Recruiting |
NCT03469531 -
Study of Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer
|
Phase 2 | |
Completed |
NCT02880007 -
Dose Optimization in 3D Pulsed Dose Rate Brachytherapy for Patients With Locally Advanced Cervical Cancer
|
Phase 2 | |
Active, not recruiting |
NCT00956670 -
Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer
|
N/A | |
Completed |
NCT00897442 -
Collecting Tumor Samples From Patients With Gynecological Tumors
|
N/A | |
Completed |
NCT01098630 -
Patient, Physician, and Nurse Factors Associated With Entry Onto Clinical Trials and Finishing Treatment in Patients With Primary or Recurrent Uterine, Endometrial, or Cervical Cancer
|
||
Completed |
NCT00941070 -
Triapine, Cisplatin, and Radiation Therapy in Treating Patients With Cervical Cancer or Vaginal Cancer
|
Phase 2 | |
Withdrawn |
NCT01019278 -
Proton Beam Radiation Therapy and Cisplatin in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer and Positive Lymph Nodes
|
Phase 2 | |
Completed |
NCT00104910 -
Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer
|
Phase 1 | |
Terminated |
NCT00262821 -
Cisplatin and Radiation Therapy With or Without Tirapazamine in Treating Patients With Cervical Cancer
|
Phase 3 | |
Completed |
NCT00107445 -
EF5 in Finding Oxygen in Tumor Cells of Patients Who Are Undergoing Surgery or Biopsy for Cervical, Endometrial, or Ovarian Epithelial Cancer
|
Phase 2 | |
Terminated |
NCT00577317 -
Flexitouch® Home Maintenance Therapy or Standard Home Maintenance Therapy in Treating Patients With Lower-Extremity Lymphedema Caused by Treatment for Cervical Cancer, Vulvar Cancer, or Endometrial Cancer
|
Phase 3 | |
Completed |
NCT03198286 -
Carevive Survivor Care Planning System in Improving Quality of Life in Breast Cancer Survivors
|
N/A | |
Completed |
NCT00460356 -
Glycoprotein and Glycan in Tissue and Blood Samples of Patients With Stage IB-IVA Cervical Cancer Undergoing Surgery to Remove Pelvic and Abdominal Lymph Nodes
|
N/A | |
Withdrawn |
NCT01313104 -
Colposcopy and High Resolution Anoscopy in Screening For Anal Dysplasia in Patients With Cervical, Vaginal, or Vulvar Dysplasia or Cancer
|
N/A |