A Phase 1 Study of 99mTc-p5+14 in Healthy Volunteers and Patients With AL or ATTR Systemic Amyloidosis
Part of Cancer, Hormones & metabolism, Immune system & allergy clinical trials.
This study will investigate 99mTc-p5+14, an amyloid-reactive synthetic peptide, p5+14, radiolabeled with technetium-99m, as a radiotracer for detecting paamyloid deposits in patients with AL or ATTR-associated systemic amyloidosis, notably with cardiac involvement.
Summary from the official registry record.
Who can take part
- PART 1
- 1\) Understand the study procedures and agree to participate in the study by giving written informed consent..
- 2\) Be male or female \>18 years of age. 3) Women of child-bearing potential (WOCBP) (those who have not been surgically sterilized, are not postmenopausal \[i.e., last menstrual period \>2 years ago without pharmaceutical intervention\], and women who are fertile) must have a negative pregnancy test prior within 24 h prior to infusion.
- 4\) WOCBP who are not exclusively in same-sex relationships and male participants with female sexual partners who are WOCBP must agree to use adequate contraceptive methods, defined as use of a condom by the male partner combined with use of a highly effective method of contraception by the female partner, for at least 2.5 days after injection of 99mTc-p5+14.
- 5\) Be a healthy volunteer (n=3) or have a confirmed diagnosis of systemic amyloidosis (n=2) based on either a histologic confirmation with a biopsy containing deposits of apple-green birefringent, Congophilic material with aberrant organ-specific biomarkers indicating amyloid involvement, physical examination, or imaging study.
- 6\) Healthy volunteers must also meet inclusion criteria for Part 3. PART 2
See the full eligibility criteria below for the complete list.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
Similar studies
Other trials that look related to this one.
This trial tests a combination of three drugs—bortezomib, pomalidomide, and dexamethasone—to see how well they work for people with AL amyloidosis, a condition where abnormal proteins build up in organs. You may join if you are newly diagnosed or have had prior treatment and your organs are affected.
This study tests a new type of heart imaging scan called [68Ga]Ga-FAPI-46 PET to help doctors see and track transthyretin cardiac amyloidosis (a disease where abnormal proteins damage the heart). The scan may help identify which patients are getting worse.
This study uses a special PET scan tracer to see how consistent the images are in people with heart amyloidosis (a buildup of abnormal protein in the heart) and in people without the condition. The goal is to improve diagnosis and monitoring.
This trial studies whether ultrasound therapy can help people with amyloidosis that affects the heart. It’s aimed at improving heart-related outcomes in AL or transthyretin (ATTR) cardiac amyloidosis.
This study collects information from adults who have been diagnosed with, or are being checked for, ATTR amyloidosis (a condition where abnormal protein builds up in the body) using a heart PYP scan. Your participation may help doctors better understand how these scans relate to diagnosis and follow-up over time.
This Phase 2 study tests an iodine-based scan medicine to help learn how systemic amyloidosis affects the body and organs. It may help doctors better characterize the disease using specific imaging tests.
Hear when a new Systemic Amyloidosis trial opens
We’ll email you when one opens — at most once a week, no account needed, unsubscribe anytime.