Clinical trials: Microdosing
Neuroendocrine Tumors
An Imaging Study of 64Cu-SARTATE Using Positron Emission Tomography in Patients With Neuroendocrine Tumours
The primary purpose of this study is to examine the safety and potential effectiveness of a drug molecule called 64Cu-SARTATE as a potential new way to detect neuroendocrine cancers.
- Trial name
- NCT04440956
- Testing
- 64Cu-SARTATE
- Volunteers
- 10 people
- Sponsor
- Clarity Pharmaceuticals Ltd
Head and Neck Squamous Cell Carcinoma
PBI-MST-01 (NCT04541108) Substudy AZN-05: Intratumoral Microdosing of Rilvegostomig, Volrustomig, Sabestomig, and AZD9592 in HNSCC
This is a multi-center, open-label, Phase 0 substudy designed to evaluate the localized pharmacodynamics (PD) of rilvegostomig, volrustomig, sabestomig, and AZD9592 within the tumor microenvironment (TME) when administered…
- Trial name
- NCT06366451
- Testing
- Rilvegostomig, Volrustomig, Sabestomig
- Where
- 7 sites in United States
- Volunteers
- 17 people
- Sponsor
- Presage Biosciences
Soft Tissue Sarcoma Adult
Precise Local Injection of Anti-cancer Drugs Using Presage's CIVO Device in Soft Tissue Sarcoma
This is a feasibility study in patients with localized or metastatic soft tissue sarcoma undergoing surgery to determine how sarcoma in situ responds to injected microdoses of anti-cancer therapeutics.
- Trial name
- NCT03056599
- Testing
- Multiple drug microinjection, CIVO device
- Where
- 3 sites in United States
- Volunteers
- 23 people
- Sponsor
- Presage Biosciences
MASH, PSC
A Microdose Trial Investigating Binding of [68Ga]Ga-DOTA-CYS-ATH001 in Healthy Subjects and Different Patient Groups.
The goal of this clinical trial is to use positron emission tomography (PET) to evaluate and compare the binding of the novel tracer [68Ga]Ga-DOTA-Cys-ATH001 in the liver and/or gastrointestinal tract between healthy volunteers…
- Conditions
- MASH, PSC, Fibrostenotic Crohn's Disease, Healthy Volunteers
- Trial name
- NCT06562361
- Testing
- [68Ga]Ga-DOTA-Cys-ATH001
- Where
- 3 sites in Sweden
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Antaros Medical
Health-Related Physical Fitness
Effects of Microdosed Resistance Training During Physical Education on Health-Related Fitness in Adolescents
This study will examine whether short bouts of resistance training incorporated into physical education lessons can improve health-related physical fitness in secondary school students aged 15-16 years.
- Trial name
- NCT07845864
- Testing
- Resistance training microdosing during physical education
- Volunteers
- 264 people, healthy volunteers welcome
- Sponsor
- Wroclaw University of Health and Sport Sciences
Acute Lung Injury
Exploratory Clinical Study of Neutrophil Activation Probe (NAP) for Optical Molecular Imaging in Human Lungs
Seriously ill patients may develop a complication called acute lung injury (ALI), a form of inflammation in which lung tissue is filled by fluid containing white blood cells called neutrophils.
- Trial name
- NAP (NCT01532024)
- Testing
- Microdose of NAP
- Where
- 3 sites in United Kingdom
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- University of Edinburgh
Breast Cancer, Healthy Volunteers
Study to Determine Absorption, Metabolism, and Excretion of [14C]-SAR439859, and to Assess Absolute Oral Bioavailability of Amcenestrant (SAR439859), in Healthy Post-menopausal Women
Primary Objectives: To assess the excretion balance after oral and IV administration of [14C]-SAR439859 To assess PK of total radioactivity, [14C] -SAR439859 and its metabolite (M7) after IV administration of [14C]-SAR439859 and…
- Trial name
- NCT04940026
- Testing
- amcenestrant, [14C]-SAR439859 microtracer, [14C]-SAR439859
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Sanofi
Head and Neck Cancer
Intratumoral Microdosing of TAK-981 in Head and Neck Cancer
This is a multi-center, single arm, open-label, multi-agent, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of TAK-981 and TAK-981 combined with…
- Trial name
- NCT04065555
- Testing
- TAK-981, Cetuximab, Avelumab
- Where
- 6 sites in United States
- Volunteers
- 12 people
- Sponsor
- Presage Biosciences
Opioid Use Disorder, Opioid Use
Novel Induction to Buprenorphine/Naloxone
Microdosing induction is a novel method of starting buprenorphine/naloxone without patients experiencing the opioid withdrawal that is a part of traditional induction.
- Conditions
- Opioid Use Disorder, Opioid Use, Opioid Abuse, Opioid Misuse
- Trial name
- NCT05644587
- Testing
- buprenorphine/naloxone
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Bicycle Health
Newly Diagnosed or Recurrent Metastatic Melanoma Patients, Malignant Brain Tumors
PET Imaging of Patients With Melanoma and Malignant Brain Tumors Using an 124I-labeled cRGDY Silica Nanomolecular Particle Tracer: A Microdosing Study
Current tests to detect cancer, including CAT scans and MRI scans, are limited. PET scans use special dyes that are injected into a vein and can better localize possible cancer.
- Trial name
- NCT01266096
- Testing
- PET scan with 124I-cRGDY-PEG-dots
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Pain, Intractable, Pain, Back
BurstDR™ micrOdosing stimuLation in De-novo Patients
The purpose of this study is to evaluate the therapeutic efficacy of microdosing BurstDR stimulation in spinal cord stimulation (SCS) patients with chronic intractable back and/or leg pain.
- Trial name
- BOLD (NCT03350256)
- Testing
- Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.
- Where
- 5 sites in United States
- Volunteers
- 60 people
- Sponsor
- Abbott Medical Devices
Opioid Use Disorder
Comparing Rapid Micro-Induction and Standard Induction of Buprenorphine/Naloxone for Treatment of Opioid Use Disorder
The current first-line treatment for opioid use disorder (OUD) in Canada is buprenorphine/naloxone (bup/nx). The standard induction method of bup/nx requires patients to be abstinent from opioids and thereby experience withdrawal…
- Trial name
- NCT04234191
- Testing
- Buprenorphine/naloxone, Hydromorphone
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- University of British Columbia
ST-Elevation Myocardial Infarction (STEMI), Heart Failure With Preserved Ejection Fraction (HFpEF)
Platelet Derived Growth Factor Receptor ß (PDGFRß) Imaging in Cardiac Fibrosis
An observational, cross-sectional, longitudinal, microdosing Position Emission Tomography (PET) imaging study to investigate platelet derived growth factor receptor beta (PDGFRß) expression in the heart of patients with high or…
- Trial name
- PARIS (NCT06956560)
- Testing
- PET/MRI or separate PET/CT and MRI
- Where
- Sweden
- Volunteers
- 30 people
- Sponsor
- Uppsala University
Weight Gain
Incretin Microdosing for Cardiometabolic Health in People With HIV
The objectives of this study are as follows: Primary Objective To determine the rate of weight regain in people living with human immunodeficiency virus (HIV) (PWH) receiving semaglutide microdosing vs.
- Trial name
- REINFORCE (NCT07325500)
- Testing
- Dose escalation to 2 mg semaglutide weekly then semaglutide microdosing at 0.5 mg weekly, Dose escalation to 2 mg semaglutide weekly then no semaglutide
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- The University of Texas Health Science Center, Houston
Pain, Acute Pain
The Role of NaV1.8 in Human Pain Models
This study aims to understand how NaV1.8, a specific type of sodium channel found in peripheral nerves, contributes to different types of pain in humans.
- Conditions
- Pain, Acute Pain, Healthy Volunteer Study
- Trial name
- NCT07511400
- Testing
- Suzetrigine, Lidocaine (drug), Control Solution
- Where
- Austria
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Medical University of Vienna
Depression, Anxiety, Distress, Emotional
PSilocybin for psYCHological and Existential Distress in PALliative Care (PSYCHED-PAL)
The goal of this multi-centre phase I/II open-label, single-arm study is to determine the safety, feasibility, therapeutic dose, and preliminary efficacy of psilocybin microdosing to treat psychological distress among patients…
- Trial name
- NCT04754061
- Testing
- Psilocybin
- Where
- 2 sites in Canada
- Volunteers
- 20 people
- Sponsor
- Ottawa Hospital Research Institute
Head and Neck Squamous Cell Carcinoma
PBI-MST-01(NCT04541108) Substudy TAK-02: Intratumoral Microdosing of TAK-676 in HNSCC
This is a multi-center, open-label Phase 0 substudy designed to study the localized pharmacodynamics (PD) of TAK-676 alone or in combination with Carboplatin, 5-FU, or Paclitaxel within the tumor microenvironment (TME) when…
- Trial name
- NCT06062602
- Testing
- TAK-676, Carboplatin, 5-FU
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Presage Biosciences
Head and Neck Squamous Cell Carcinoma, Soft Tissue Sarcoma
PBI-MST-01 (NCT04541108) Substudy MSD-03: Intratumoral Microdosing of Pembrolizumab Alone and With MK-0482 or MK-4830 in HNSCC or STS
This is a multi-center, open-label, Phase 0 substudy designed to evaluate the ability of pembrolizumab, alone and in combination with MK-0482 or MK-4830, to elicit pharmacodynamic changes suggestive of antitumor immune activation…
- Trial name
- NCT06413095
- Testing
- Pembrolizumab, MK-0482 + Pembrolizumab, MK-4830 + Pembrolizumab
- Where
- 11 sites in United States
- Volunteers
- 13 people
- Sponsor
- Presage Biosciences
Head and Neck Squamous Cell Carcinoma, Soft Tissue Sarcoma Adult
A Study of the Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors
This is a multi-center, single arm, open-label, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of PBA-0405 when administered intratumorally in…
- Conditions
- Head and Neck Squamous Cell Carcinoma, Soft Tissue Sarcoma Adult, Triple Negative Breast Cancer
- Trial name
- NCT06273852
- Testing
- PBA-0405
- Where
- 4 sites in United States
- Volunteers
- 8 people
- Sponsor
- Pure Biologics S.A.
Opioid Use Disorder, Opioid Withdrawal
Evaluating the Pharmacokinetics and Patient Outcomes of Buprenorphine Microdosing
There are more than 2.1 million people in the United States with opioid use disorder, and according to preliminary data from the US Centers for Disease Control and Prevention opioid overdose deaths rose 36% to more than 69,000…
- Trial name
- NCT05307458
- Testing
- Buprenorphine/naloxone
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- United Health Services Hospitals, Inc.