Clinical trial NCT04870645
Conditions: Malignant Solid Neoplasm
Sponsor: M.D. Anderson Cancer Center
Start date: 2021-03-30; Completion date: 2023-08-29
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This clinical trial studies the different types of investigational imaging techniques called sequences during magnetic resonance imaging (MRI) of the head before and after radiation therapy in patients with cancer that has spread to the brain (intracranial metastases). This clinical trial also compares these new techniques with standard MRI imaging to see if sequences provide better images. Diagnostic procedures, such as MRI, may help find and diagnose solid organ cancer and find out how far the disease has spread.

Detailed description:
PRIMARY OBJECTIVES:

I. Conspicuity:

Ia. To assess the conspicuity of idealized T1 and T2 imaging at detecting brain metastases at baseline. (Quantitative MRI) Ib. To assess the conspicuity (CNR) of chemical exchange saturation transfer (CEST) imaging at detecting brain metastases at baseline. (CEST MRI) Ic. To assess the conspicuity (CNR) of advances in difference equations (Adv Diff) at detecting brain metastases at baseline. (Multiple B Value Diffusion Imaging \[Adv Diff\]) Id. To assess the conspicuity of gradient- and spin-echo (GESE) dynamic susceptibility contrast (DSC) and standard Gradient Echo (GE) DSC at detecting brain metastases at baseline. (GESE DSC perfusion imaging)

SECONDARY OBJECTIVES:

I. Conspicuity:

Ia. To assess the conspicuity of T2 imaging at detecting brain metastases on a per-patient basis at follow-up scans and on a per-lesion basis at baseline and at follow-up time points. (Quantitative MRI) Ib. To assess the conspicuity (CNR) of CEST imaging at detecting brain metastases on a per-patient basis at follow-up scans and on a per-lesion basis at baseline and at follow-up time points. (CEST MRI) Ic. To assess the conspicuity (CNR) of Adv Diff at detecting brain metastases on a per-patient basis at follow-up scans and on a per-lesion basis at baseline and at follow-up time points. (Multiple B Value Diffusion Imaging \[Adv Diff\]) Id. To assess the conspicuity of GESE DSC and standard Gradient Echo (GE) DSC at detecting brain metastases on a per-patient basis at follow-up scans and on a per-lesion basis at baseline and at follow-up time points. (GESE DSC perfusion imaging) II. Treatment response. IIa. To assess the trend of idealized quantitative T1 and T2 values of brain metastases compared to normal brain parenchyma following treatment with stereotactic radiosurgery. (Quantitative MRI) IIb. To assess the ability of CEST imaging to differentiate radiation necrosis from progressive disease in brain metastases following stereotactic radiosurgery. (CEST MRI) IIc. To assess whether Adv Diff can differentiate radiation necrosis from progressive disease in brain metastases following stereotactic radiosurgery. (Multiple B Value Diffusion Imaging \[Adv Diff\]) IId. To assess whether GESE DSC improves differentiation of radiation necrosis from progressive disease in brain metastases following stereotactic radiosurgery compared to standard GE DSC. (GESE DSC perfusion imaging) IIe. To assess the ability of Adv arterial spin labeling (ASL) to differentiate radiation necrosis from progressive disease in brain metastases following stereotactic radiosurgery. (Multiple inversion time \[TI\] ASL "Adv ASL" perfusion)

OUTLINE:

Patients undergo conventional and advanced MRI scans over 60 minutes within 14 days before the start of scheduled brain radiation treatment. Patients then undergo 7 additional MRI scans over 60 minutes each between 4-16 weeks apart. Patients may receive gadolinium and/or iopamidol during MRI scans.

Arms: arm 1: Patients undergo conventional and advanced MRI over 60 minutes within 14 days before the start of scheduled brain radiation treatment. Patients then undergo 7 additional MRI over 60 minutes each between 4-16 weeks apart. Patients may receive gadolinium and/or iopamidol during MRI scans.
Interventions: intervention 1: Advanced Magnetic Resonance Imaging intervention 2: Conventional Magnetic Resonance Imaging intervention 3: Gadolinium-Chelate intervention 4: Iopamidol
Intervention descriptions: intervention 1: Undergo advanced MRI intervention 2: Undergo conventional MRI intervention 3: Contrast agent intervention 4: Contrast agent

Protocol documents:
Prot_SAP_000.pdf: 
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Proprietary Information of MD Anderson

ICF_001.pdf: 
Protocol 2019-1008 
September 28, 2022 
Page 1 of 8 
 
 
Informed Consent 
 
 
INFORMED CONSENT/AUTHORIZATION FOR PARTICIPATION IN 
RESEARCH 
 
Advanced MRI for Intracranial Metastasis Treated with Stereotactic 
Radiosurgery 
2019-1008 
 
 
Study Chair:  Jason Johnson, MD 
 
_________________________ _____________________ 
Participant’s Name  
 
Medical Record Number  
 
This is an informed consent and authorization form for a research study. It includes a 
summary about the study. A more detailed description of procedures and risks is 
provided after the summary. 
 
This research has been reviewed and approved by an Institutional Review Board 
(IRB - a committee that reviews research studies). 
 
STUDY SUMMARY 
 
The goal of this clinical research trial is to study different types of investigational 
imaging techniques (called “sequences”) during MRIs of the head before and after 
radiation therapy in patients with intracranial metastases (cancer that has spread to 
the brain). The researchers will also compare these new techniques with standard 
MRI imaging to see if the investigational techniques provide better images.  
 
One of these sequences (acidoCEST) involves imaging before and after injection of a 
contrast (iopamidol), which is an FDA approved agent for CT imaging. Its use for this 
purpose is considered investigational. Patients with a history of kidney problems or 
prior reaction to imaging contrast agents will NOT be offered this portion of the study. 
 
This is an investigational study. Most of the MRI sequences are delivered using 
FDA approved and commercially available methods. Some of the imaging sequences 
used in this study are not FDA approved or commercially available. It is considered 
investigational to use these imaging techniques as well as acidoCEST imaging with 
iopamidol during the MRI. 
 


Protocol 2019-1008 
September 28, 2022 
Page 2 of 8 
 
The MRI you receive on this study could provide better quality images than you 
would normally receive from a standard MRI scan. Future patients may benefit from 
what is learned. There may be no benefits for you in this study.  
 
Your participation is completely voluntary. Before choosing to take part in this study, 
you should discuss with the study team any concerns you may have, including time 
commitment. Your MRI will take longer to complete than the standard-of-care MRI.  
 
You can read a list of potential side effects below in the Possible Risks section of 
this consent. 
 
Your participation in this study will be over after your last research MRI is completed.  
 
The research MRI and acidoCEST imaging with iopamidol will be provided at no cost 
to you while you are on study. You and/or your insurance provided will be 
responsible for the cost of the standard-of-care MRI and contrast drug. 
 
You may choose not to take part in this study. The study doctor will discuss the 
possible risks and benefits of this option.  Instead of taking part in this study, you may 
choose to receive a standard MRI without the investigational sequences used in this 
study. You may choose to receive other investigational therapy, if available. You may 
choose not to have treatment for cancer at all. In all cases, you will receive 
appropriate medical care, including treatment for pain and other symptoms of cancer. 
 
 
1. STUDY DETAILS 
 
Up to 50 patients will be enrolled in this study. All will take part at MD Anderson. 
 
Imaging Visits 
If you agree to take part in this study, you will visit the Diagnostic Imaging Clinic 8 
times to have MRIs performed. The first visit will occur within 14 days before your 
scheduled radiation therapy (a baseline visit). The other 7 visits will occur every 4-
16 weeks after the start of your radiation therapy.  
 
At each visit, you will have two (2) types of MRI sequences: standard-of-care MRI 
sequences (nearly identical to what you would receive if you did not take part in 
this study) and the study’s investigational research sequences (which may include 
acidoCEST). Your routine MRI of the brain can be scheduled and performed along 
with the research MRI scan. The research sequences will add about 30 minutes to 
your appointment.  
 
The total time for each imaging visit should be about 1 hour.  
 
 
2. POSSIBLE RISKS 
 


Protocol 2019-1008 
September 28, 2022 
Page 3 of 8 
 
While on this study, you are at risk for side effects. You should discuss these with the 
study doctor. The known side effects are listed in this form, but they will vary from 
person to person. 
 
During the MRI, you may feel mild vibrations throughout your body. The machine will 
produce a loud knocking noise. This is normal. You will be given earplugs to protect 
your ears. Some people, especially those who tend to feel uncomfortable in small or 
closed spaces, may feel “closed in” and become anxious while in the scanner. The 
scanner has an intercom, which will allow you to speak to the staff during the 
procedure. If you feel ill or anxious during scanning, tell the MRI staff and the 
scanning will be stopped if you wish. The MRI will require a catheter to be inserted 
into one of your veins in order to inject the MRI imaging agent. This may cause skin 
irritation, bleeding, and/or infection. You may have an allergic reaction to the imaging 
agent. 
 
The magnetic field used in MRI scanning may harm you if you have certain types of 
metal in your body (as might be found in pacemakers, neurostimulators, or certain 
clips). It may cause problems with devices, such as pacemakers. If you have metal in 
your body or devices such as a pacemaker, you should discuss this with the study 
doctor. 
 
Iopamidol is FDA approved as a contrast agent for CT imaging and is considered 
safe for most people. Iopamidol may cause a feeling of warmth or pain at the 
injection site. It may cause nausea, vomiting, headache, dizziness, and/or heart and 
kidney complications. It may cause allergic reactions, which may include breathing 
and/or skin problems (rash, redness, blisters, itching, and/or local swellings) and may 
appear either right away or up to a few days after the injection. It may cause water to 
collect in the lungs and/or anaphylactic shock (a severe allergic reaction that can 
cause breathing difficulty and/or a drop in blood pressure). It may cause changes in 
the way you move or changes in your senses. If you have had a prior reaction 
iopamidol or another CT contrast agent, please tell the research staff as this portion 
of the study may not be safe for you. 
 
This study may involve unpredictable risks to the participants. 
 
 
3. COSTS AND COMPENSATION  
 
If you suffer injury as a direct result of taking part in this study, MD Anderson health 
providers will provide medical care. However, this medical care will be billed to your 
insurance provider or you in the ordinary manner. You will not be reimbursed for 
expenses or compensated financially by MD Anderson this injury. You may also 
contact the Chair of MD Anderson’s IRB at 713-792-6477 with questions about 
study-related injuries. By signing this consent form, you are not giving up any of 
your legal rights. 
 
Certain tests, procedures, and/or drugs that you may receive as part of this study 
may be without cost to you because they are for research purposes only. However, 


Protocol 2019-1008 
September 28, 2022 
Page 4 of 8 
 
your insurance provider and/or you may be financially responsible for the cost of 
care and treatment of any complications resulting from the research tests, 
procedures, and/or drugs. Standard medical care that you receive under this 
research study will be billed to your insurance provider and/or you in the ordinary 
manner. Before taking part in this study, you may ask about which parts of the 
research-related care may be provided without charge, which costs your insurance 
provider may pay for, and which costs may be your responsibility. You may ask 
that a financial counselor be made available to you to talk about the costs of this 
study.   
 
There are no plans to compensate you for any patents or discoveries that may 
result from your participation in this research.  
 
Although every effort will be made to keep study data safe, there is a chance that 
your personal health information could be lost or stolen, which may result in a loss of 
confidentiality. All study data will be stored in password-protected computers and/or 
locked file cabinets during the study and will continue to be stored securely after the 
study. Only authorized study members will have access to study data. 
 
You will receive no compensation for taking part in this study.  
 
 
Additional Information  
 
4. You may ask the study chair (Dr. Jason Johnson, at 713-792-8443) any questions 
you have about this study. You may also contact the Chair of MD Anderson's 
Institutional Review Board (IRB - a committee that reviews research studies) at 713-
792-6477 with any questions that have to do with this study or your rights as a study 
participant. 
 
5. You may choose not to take part in this study without any penalty or loss of benefits 
to which you are otherwise entitled. You may also withdraw from participation in this 
study at any time without any penalty or loss of benefits. If you decide you want to 
stop taking part in the study, it is recommended for your safety that you first talk to 
your doctor. If you withdraw from this study, you can still choose to be treated at MD 
Anderson. 
 
If you stop being in the research, already collected data may not be removed from 
the study database. You may be asked whether the study doctor can continue to 
collect data from your routine medical care. If you agree, this data will be handled 
the same as research data. 
 
6. This study or your participation in it may be changed or stopped without your 
consent at any time by the study chair, the U.S. Food and Drug Administration 
(FDA), the Office for Human Research Protections (OHRP), or the IRB of MD 
Anderson. 
 
7. You will be informed of any new findings or information that might affect your 


Protocol 2019-1008 
September 28, 2022 
Page 5 of 8 
 
willingness to continue taking part in the study, including the results of all of your 
standard tests performed as part of this research, and you may be asked to sign 
another informed consent and authorization form stating your continued willingness 
to participate in this study. 
 
You will receive the results of your research MRI, but the test results will not be 
included in your medical record or used in your treatment planning. 
 
8. MD Anderson may benefit from your participation and/or what is learned in this 
study. 
 
 
Future Research 
 
Your personal information is being collected as part of this study. This information, 
or data, may be used by researchers at MD Anderson or shared with other 
researchers and/or institutions for use in future research.  
 
Before being shared for future research, every effort will be made to remove your 
identifying information from any data. If all identifying information is removed, you 
will not be asked for additional permission before future research is performed.  
 
In some cases, all of your identifying information may not be removed before your 
data are used for future research. If this research is performed at MD Anderson, the 
researchers must get approval from the Institutional Review Board (IRB) of MD 
Anderson before your data can be used. At that time, the IRB will decide whether or 
not further permission from you is required. The IRB is a committee of doctors, 
researchers, and community members that is responsible for protecting study 
participants and making sure all research is safe and ethical.  
 
If you do not want your data to be used for future research, tell the study doctor. 
You may withdraw your participation at any time by telling your study team. If you 
decide to withdraw, the data and test results already collected from your scheduled 
procedures will be kept and may be used. 
 
If this research is not performed at MD Anderson, MD Anderson will not have 
oversight of any data. 
 
 
Authorization for Use and Disclosure of Protected Health Information (PHI): 
 
A. During the course of this study, MD Anderson will be collecting and using your PHI, 
including identifying information, information from your medical record, and study 
results. For legal, ethical, research, and safety-related reasons, your doctor and the 
research team may share your PHI with: 
• Federal agencies that require reporting of clinical study data (such as the FDA, 
National Cancer Institute [NCI], and OHRP) 
• The IRB and officials of MD Anderson 


Protocol 2019-1008 
September 28, 2022 
Page 6 of 8 
 
• Study monitors and auditors who verify the accuracy of the information 
• Individuals who put all the study information together in report form 
 
 
The data collected about you will be labeled with a code and will not contain 
information that will identify you, such as your name or age. All MR imaging data 
will be kept per MD Anderson policy on password protected computers behind the 
institution firewall for future review and the research project. This data will be 
stored 5 years after the end of the study and only study staff working on this project 
will have access to it. 
 
The results of this research may be published in scientific journals or presented at 
medical meetings, but your identity will not be disclosed. 
 
B. Signing this consent and authorization form is optional but you cannot take part in 
this study or receive study-related treatment if you do not agree and sign. 
 
C. MD Anderson will keep your PHI confidential when possible (according to state and 
federal law). However, in some situations, the FDA could be required to reveal the 
names of participants. 
 
Once disclosed outside of MD Anderson, federal privacy laws may no longer protect 
your PHI. 
 
D.  The permission to use your PHI will continue indefinitely unless you withdraw your 
authorization in writing. Instructions on how to do this can be found in the MD 
Anderson Notice of Privacy Practices (NPP) or you may contact the Chief Privacy 
Officer at 713-745-6636. If you withdraw your authorization, you will be removed 
from the study and the data collected about you up to that point can be used and 
included in data analysis. However, no further information about you will be 
collected. 
 
E. A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law. This Web site will not include information that can identify you. 
At most, the Web site will include a summary of the results. You can search this 
Web site at any time. 
 


Protocol 2019-1008 
September 28, 2022 
Page 7 of 8 
 
CONSENT/AUTHORIZATION 
 
I understand the information in this consent form.  I have had a chance to read the 
consent form for this study, or have had it read to me. I have had a chance to think about 
it, ask questions, and talk about it with others as needed. I give the study chair 
permission to enroll me on this study.  By signing this consent form, I am not giving up 
any of my legal rights. I will be given a signed copy of this consent document. 
 
________________________________________ 
_______ 
SIGNATURE OF PARTICIPANT 
DATE 
 
_________________________________         
PRINTED NAME OF PARTICIPANT                 
 
 
WITNESS TO CONSENT 
I was present during the explanation of the research to be performed under Protocol 
2019-1008. 
 
_____________________________________________________  
_________ 
SIGNATURE OF WITNESS TO THE VERBAL CONSENT  
  
DATE  
PRESENTATION (OTHER THAN PHYSICIAN OR STUDY CHAIR) 
A witness signature is only required for vulnerable adult participants. If witnessing the assent of a pediatric 
participant, leave this line blank and sign on the witness to assent page instead. 
 
 
 
PRINTED NAME OF WITNESS TO THE VERBAL CONSENT 
 
PERSON OBTAINING CONSENT 
I have discussed this research study with the participant and/or his or her authorized 
representative, using language that is understandable and appropriate.  I believe that I 
have fully informed this participant of the nature of this study and its possible benefits 
and risks and that the participant understood this explanation. 
 
______________________________________________ 
  
_________ 
PERSON OBTAINING CONSENT  
 
 
 
 
 
DATE 
 
______________________________________________ 
PRINTED NAME OF PERSON OBTAINING CONSENT 
TRANSLATOR 
I have translated the above informed consent as written (without additions or 
subtractions) into 
and assisted the people 
(Name of Language) 
obtaining and providing consent by translating all questions and responses during the 
consent process for this participant. 
 
 
_____________________       _______________________________   ___________ 


Protocol 2019-1008 
September 28, 2022 
Page 8 of 8 
 
NAME OF TRANSLATOR       SIGNATURE OF TRANSLATOR 
DATE 
 
   Please check here if the translator was a member of the research team.  (If checked, 
a witness, other than the translator, must sign the witness line below.) 
 
____________________________________________________  ___________ 
SIGNATURE OF WITNESS TO THE VERBAL TRANSLATION  
 DATE  
(OTHER THAN TRANSLATOR, PARENT/GUARDIAN,  
OR STUDY CHAIR) 
 
_____________________________________________________ 
PRINTED NAME OF WITNESS TO THE VERBAL TRANSLATION