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Radiopharmaceutical
68Ga-R8760 Imaging for Adrenocortical Cancer
Phase 1
Recruiting
Research Sponsored by Radionetics Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate hepatic function as defined below: Serum alanine aminotransaminase (ALT)/ aspartate aminotransaminase (AST) ≤3 × upper limit of normal (ULN) or ≤5 × ULN if liver metastases are present or received prior mitotane therapy, and Serum bilirubin - total ≤1.5 × ULN (unless due to Gilbert's syndrome or hemolysis in which case total ≤3.0 × ULN)
Newly diagnosed or recurrent/relapsed ACC with at least 1 measurable target lesion per RECIST v1.1 criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights
Study Summary
This trial tests a new imaging technique to detect and measure a cancer in people with adrenal gland tumors, and in healthy volunteers.
Who is the study for?
This trial is for adults with a BMI of 18-32 and adrenocortical carcinoma (ACC), either newly diagnosed or recurrent, who have at least one measurable lesion. They must be in relatively good health (ECOG ≤2) and have proper liver and kidney function. Participants need to agree to use contraception if applicable, understand the study, and sign consent forms. Exclusions include recent strokes, surgeries, acute illnesses, unstable heart conditions, other cancers that could affect results, certain infections like HIV or hepatitis B/C.Check my eligibility
What is being tested?
The Phase 1 trial tests the safety and dosage levels of an injectable radioactive tracer called 68Ga-R8760 in patients with ACC as well as healthy volunteers. The goal is to determine how much of this substance can be safely used while assessing its distribution within the body.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions related to injection such as pain or swelling at the injection site. Since it's a radioactive substance being tested for safety/dosage levels, there might also be risks associated with radiation exposure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver is functioning within the required limits for the trial.
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I have a new or returning adrenal cancer with a measurable tumor.
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I am an adult over 18 and not pregnant or breastfeeding if female.
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I can take care of myself but might not be able to do heavy physical work.
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My cancer is confirmed to be adrenal cortical carcinoma.
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I am a healthy adult between 18 and 59 years old and not pregnant or breastfeeding.
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My kidneys work well, with a creatinine clearance of 60 mL/min or more.
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My kidneys are working well, with a creatinine clearance of 60 mL/min or more.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Absorbed dose coefficients (mGy/MBq) in target organs and the effective dose coefficient (mSv/MBq)
Incidence of adverse events characterized overall and by type, frequency, seriousness, relationship to study drug, timing and severity graded according to the NCI-CTCAE v5.0; absolute values and changes in clinical laboratory parameters
Secondary outcome measures
Area under the plasma concentration versus time curse (AUC)
Half-life (T1/2) of 68Ga-R8760
Maximum plasma concentration (Cmax)
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: 68Ga-R8760 Expansion Cohort (Part 2)Experimental Treatment1 Intervention
Group II: 68Ga-R8760 Dose Selection (Part 1)Experimental Treatment1 Intervention
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Radionetics OncologyLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't donated blood, plasma, or platelets recently.My liver is functioning within the required limits for the trial.I have not had radiotherapy in the last 14 days.I am currently on antibiotics for a serious infection.I have a new or returning adrenal cancer with a measurable tumor.My heart's electrical system does not have long QT syndrome and my QTcF is within normal range.I am an adult over 18 and not pregnant or breastfeeding if female.I can take care of myself but might not be able to do heavy physical work.I have had surgery to remove one or both of my adrenal glands.I haven't had major surgery in the last 3 weeks or still recovering from one.Your heart rate at rest is either too fast (more than 100 beats per minute) or too slow (less than 40 beats per minute). If this is the case, the doctor will check it again to make sure.I do not have severe heart problems or uncontrolled health conditions.I don't have another cancer that would affect the safety of this trial.I do not have an active HIV, Hepatitis B, or Hepatitis C infection.I am not mentally or legally incapacitated.Your blood pressure is too high or too low, unless the doctor says it's not a problem.I haven't used any steroid creams or pills in the last 4 weeks, but I may have used inhalers.I have had a serious infection or get infections often due to a health condition.I haven't had a radionuclide treatment recently.My cancer is confirmed to be adrenal cortical carcinoma.Your body mass index (BMI) is between 18.0 and 32.0 kg/m2.I am a healthy adult between 18 and 59 years old and not pregnant or breastfeeding.My kidneys work well, with a creatinine clearance of 60 mL/min or more.My kidneys are working well, with a creatinine clearance of 60 mL/min or more.I agree to use effective birth control during the study.I have been diagnosed with an adrenal gland disorder.I had a stroke within the last 6 months or it caused lasting neurological issues.I haven't had a severe illness in the last 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: 68Ga-R8760 Dose Selection (Part 1)
- Group 2: 68Ga-R8760 Expansion Cohort (Part 2)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any vacancies in this research endeavor?
"According to the records posted on clinicaltrials.gov, this experiment is currently looking for participants; it was initiated on August 1st 2023 with a recent update being done on August 11th 2023."
Answered by AI
What is the aggregate population size of individuals enrolled in this experiment?
"Affirmative. According to information hosted on clinicaltrials.gov, this medical experiment has been live since August 1st 2023 and is actively enrolling participants as of the most recent edit made 11 days later. A total of 25 subjects need to be recruited from one site."
Answered by AI
Do regulatory authorities bless a certain dosage for 68Ga-R8760 injection?
"As this is a Phase 1 trial, and therefore only minimal clinical evidence exists to support the safety of 68Ga-R8760 injection at pre-defined dose levels, our team has assigned it a rating of 1."
Answered by AI
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