免费获得国外相关药品，最快 1 个工作日回馈药物信息
出境医 / 临床实验 / 68 Ga PSMA PET/MRI for Hepatocellular Carcinoma
68 Ga PSMA PET/MRI for Hepatocellular Carcinoma
Study Description
Brief Summary:
This is a pilot study to investigate the evaluate to use of a drug/radiopharmaceutical called Gallium-68 PSMA-11 (68Ga-PSMA-11) for use in PET/MRI evaluation of hepatocellular carcinoma
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatocellular Carcinoma | Drug: 68Ga-PSMA-11 PET/MRI | Phase 1 Phase 2 |
Detailed Description:
This is a prospective pilot proof-of-concept single-center study. Primary Objective Using surgical histopathology as the reference standard, the investigators intend to achieve the following objectives in adult subjects with Hepatocellular Carcinoma (HCC) undergoing surgical resection or transplant:
- To demonstrate the feasibility of 68Ga-PSMA-PET/MRI for imaging patients with HCC
- To estimate the sensitivity of SUVmax on PSMA PET for identification of LI-RADS® 5 (definitely HCC) observations or biopsy proven HCC(s).
- To perform a Radiology-Pathology correlation of PSMA uptake at PET with HCC tumor PSMA immunostaining, tumor pathology features, and signal and enhancement characteristics at MRI
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 10 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Pilot Study of Integrated Time-of-Flight (TOF) 68 GA-PSMA - Gadoxetate PET/MR for Evaluation of Hepatocellular Carcinoma |
| Actual Study Start Date : | June 27, 2019 |
| Estimated Primary Completion Date : | June 1, 2021 |
| Estimated Study Completion Date : | June 1, 2022 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Ga68 PSMA PET-MR
68Ga labeled PSMA -11 (or PSMA-HBED_CC) PET/MRI scan
|
Drug: 68Ga-PSMA-11 PET/MRI
The PET/MRI exam-related patient visit will last approximately 2 to 2.5 hours, including 30-minute nursing assessment, 45-60 minutes for PSMA uptake and 60 minutes for PET/MRI scan. They will be contacted within the next 72 hours to complete a brief phone survey.
|
Outcome Measures
Primary Outcome Measures :
- Evaluation of PSMA PET-MR for identification of intra and extrahepatic hepatocellular carcinoma in patients [ Time Frame: 18 months ]Sensitivity of PSMA PET-MRI for detection of LI-RADS 5 (definitely HCC) lesions on a per-lesion basis with histopathology as the gold standard. We will perform a Radiologic-pathologic correlation comparing HCC PSMA SUVmax with tumor PSMA immunostaining positivity.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients at risk for HCC with either an imaging diagnosis of HCC by ceCT or ceMRI (LI-RADS 5) confirmed by a board-certified abdominal radiologist or biopsy-proven HCC confirmed by a hepatobiliary pathologist
- No prior treatment for HCC
- Subjects who are expected to undergo surgical resection of the hepatic lesion(s) and/or liver transplant
- Male or female with age greater than 18 years, with the capacity to give informed consent and willingness to provide a written consent.
Exclusion Criteria:
- Subjects requiring emergent surgery for a ruptured/bleeding HCC
- Bilirubin > 3.0 mg/dL, which is a contraindication for Gadoxetate, the MRI contrast agent
- Pregnant and/or breast-feeding subjects. A negative pregnancy test within 48 hours of the PET scan.
- Subjects with higher than the weight/size limitations of PET/MRI scanner.
- Subjects with contraindication to MRI including: Subjects who have a heart pacemaker, subjects who have a metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain, subjects who have implanted devices with magnets, subjects who have other implanted electronic devices, subjects who have deep brain stimulator, subjects who have vagal nerve stimulator, subjects with cochlear (ear) or auditory implants
- Subjects with history of allergic response to radiocontrast media
- Subjects with known history of claustrophobia.
Contacts and Locations
Contacts
| Contact: Lori Lutzke | 507-284-4377 | RSTMIRPETCTF@mayo.edu | |
| Contact: Kera Delaney | 507-284-4377 | RSTMIRPETCTF@mayo.edu |
Locations
| United States, Minnesota | |
| Mayo Clinic in Rochester | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Clinical Trials Referral Office 855-776-0015 mayocliniccancerstudies@mayo.edu | |
| Principal Investigator: Ajit H. Goenka, M.D. | |
Sponsors and Collaborators
Ajit H. Goenka, MD
Investigators
| Principal Investigator: | Ajit H Goenka, MD | Mayo Clinic |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 5, 2019 | ||||||||
| First Posted Date ICMJE | June 11, 2019 | ||||||||
| Last Update Posted Date | November 2, 2020 | ||||||||
| Actual Study Start Date ICMJE | June 27, 2019 | ||||||||
| Estimated Primary Completion Date | June 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Evaluation of PSMA PET-MR for identification of intra and extrahepatic hepatocellular carcinoma in patients [ Time Frame: 18 months ] Sensitivity of PSMA PET-MRI for detection of LI-RADS 5 (definitely HCC) lesions on a per-lesion basis with histopathology as the gold standard. We will perform a Radiologic-pathologic correlation comparing HCC PSMA SUVmax with tumor PSMA immunostaining positivity.
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | 68 Ga PSMA PET/MRI for Hepatocellular Carcinoma | ||||||||
| Official Title ICMJE | Pilot Study of Integrated Time-of-Flight (TOF) 68 GA-PSMA - Gadoxetate PET/MR for Evaluation of Hepatocellular Carcinoma | ||||||||
| Brief Summary | This is a pilot study to investigate the evaluate to use of a drug/radiopharmaceutical called Gallium-68 PSMA-11 (68Ga-PSMA-11) for use in PET/MRI evaluation of hepatocellular carcinoma | ||||||||
| Detailed Description |
This is a prospective pilot proof-of-concept single-center study. Primary Objective Using surgical histopathology as the reference standard, the investigators intend to achieve the following objectives in adult subjects with Hepatocellular Carcinoma (HCC) undergoing surgical resection or transplant:
|
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 1 Phase 2 |
||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
||||||||
| Condition ICMJE | Hepatocellular Carcinoma | ||||||||
| Intervention ICMJE | Drug: 68Ga-PSMA-11 PET/MRI
The PET/MRI exam-related patient visit will last approximately 2 to 2.5 hours, including 30-minute nursing assessment, 45-60 minutes for PSMA uptake and 60 minutes for PET/MRI scan. They will be contacted within the next 72 hours to complete a brief phone survey.
|
||||||||
| Study Arms ICMJE | Experimental: Ga68 PSMA PET-MR
68Ga labeled PSMA -11 (or PSMA-HBED_CC) PET/MRI scan
Intervention: Drug: 68Ga-PSMA-11 PET/MRI
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
10 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | June 1, 2022 | ||||||||
| Estimated Primary Completion Date | June 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03982407 | ||||||||
| Other Study ID Numbers ICMJE | 18-011263 NCI-2019-08426 ( Other Identifier: NCI ) MC1944 ( Other Identifier: Mayo Clinic ) |
||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
|
||||||||
| IPD Sharing Statement ICMJE |
|
||||||||
| Responsible Party | Ajit H. Goenka, MD, Mayo Clinic | ||||||||
| Study Sponsor ICMJE | Ajit H. Goenka, MD | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| PRS Account | Mayo Clinic | ||||||||
| Verification Date | October 2020 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||
