Gadolinium Deposition DiseaseEarly Phase 1NCT05359835
DTPA (Diethylenetriaminepenta-acetate) Chelation for Symptoms After Gadolinium-assisted MRI Exposure
A Early Phase 1 study testing Calcium DTPA and Zinc DTPA in people with Gadolinium Deposition Disease, run by Stanford University at 1 site in United States.
Trial summary
The study aims at gathering additional data on the safety and effectiveness of using intravenous administration of the drugs Ca-DTPA/Zn-DTPA to remove the heavy metal gadolinium from the bodies of patients who have retained it and developed symptoms of Gadolinium Deposition Disease following an MRI in which a… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gadolinium Deposition Disease
- What is being tested?
- Calcium DTPA and Zinc DTPA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2023to 13 Sep 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 - 65 and able to give informed consent.
- Have had an MRI with contrast at least 3 months and less than 3 years before study enrollment.
- Have a 24-hour urine analysis 30 days or more post-MRI that documents abnormally high levels of gadolinium excretion.
- Exhibit within 30 days of the contrast-assisted MRI new onset of 3 or more of the following symptoms:
- cognitive disturbance,
- extremity pain,
Show all 14Show fewer
- frequent headaches,
- chest wall pain,
- skin induration,
- skin hyper-pigmentation,
- skin pain,
- arthralgia.
- Have met these Gadolinium Deposition Disease (GDD) diagnostic criteria for at least 3 months.
- Received the MRI contrast agent Gadobutrol (Gadovist) and no other MRI contrast agents.
Who cannot join
- Diagnosed by the patient's treating MD with an autoimmune or rheumatological disorder such as systemic lupus, rheumatoid arthritis or scleroderma;
- diagnosed by the patient's treating MD with a condition or conditions that could cause 3 or more of the 8 diagnostic symptoms of GDD;
- taking a medication or medications that could cause 3 or more of the 8 diagnostic symptoms of GDD;
- having a condition or conditions and taking a medication or medications that together might account for the presence of 3 or more of the diagnostic symptoms of GDD.
- Having Wilson's Disease, hemochromatosis, cancer (other than non-melanoma skin cancer), impaired kidney function, or heart disease compromising cardiac function or causing arrhythmia;
- Participating in another protocol involving a pharmacological or other treatment of GDD.
Show all 10Show fewer
- Suffering from a disorder that could raise particular cytokine levels. In addition to autoimmune and rheumatological conditions, these disorders include diabetes mellitus requiring insulin, chronic fatigue syndrome, active infectious disease, covid infection in the past four months, receipt of blood products in the previous 6 months, major depression, and irritable bowel syndrome.
- Unable for medical reasons or unwilling to discontinue medications known to lower cytokine levels of interest including: lithium, n-acetylcysteine, aspirin, NSAIDs, sertraline and other Selective Serotonin Reuptake Inhibitor antidepressants, and the over-the-counter supplements ashwagandha, astaxanthin, and milk thistle.
- Prior chelation treatment for GDD.
- Pregnant, nursing, intending to become pregnant in the next 6 months, unwilling to utilized an approved, effective contraception method during the study's duration.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: DTPA Chelation for Symptoms After Gadolinium-assisted MRI
The study aims at gathering additional data on the safety and effectiveness of using intravenous administration of the drugs Ca-DTPA/Zn-DTPA to remove the heavy metal gadolinium from the bodies of patients who have retained it and developed symptoms of Gadolinium Deposition Disease following an MRI in which a gadolinium-containing contrast agent was utilized. The outcome data will include measures of symptom relief after as many as six paired Calcium-DTPA/Zinc-DTPA chelation treatments. The study also aims at gathering additional data before and after DTPA treatment regarding levels of certain cytokines in the patients' blood that have been reported to be abnormally elevated in patients with retained gadolinium.
Read the detailed description
This study aims at gathering additional data on the safety and effectiveness of using intravenous administration of the drug DTPA to remove the heavy metal gadolinium from the bodies of patients who have retained it and developed symptoms of Gadolinium Deposition Disease following an MRI in which a gadolinium-containing contrast agent was utilized. The outcome data will include measures of symptom relief, including chronic pain, skin changes, and cognitive complaints, after as many as six paired Calcium-DTPA/Zinc-DTPA chelation treatments. The study also aims at gathering additional data before and after DTPA treatment regarding levels of certain cytokines (chemical messengers) in the patients' blood that have been reported to be abnormally elevated in patients with retained gadolinium.
DTPA is approved as safe and effective by the federal Food and Drug Administration for the removal of certain radioactive heavy metals, has been in use for more than 60 years, is well tolerated, and has been safely used in three studies, that enrolled 25, 21 and 4 patients respectively who were diagnosed with Gadolinium Deposition Disease.Only the first study reported on symptom improvement, and noted that almost all patients experienced benefit after three paired Calcium-DTPA/Zinc-DTPA chelation treatments.
- Conditions
- Gadolinium Deposition Disease
- Being tested
- Calcium DTPA and Zinc DTPA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium DTPA and Zinc DTPADrug
Also called Diethylenetriaminepenta-acetate
Intravenous administration of 2.5 mL (500 mg) of Ca-DTPA over one minute, followed by 900 mL of normal saline infusion over about 90 minutes, followed by 2.5 mL (500 mg) of Ca-DTPA over one minute, followed by infusion of the remaining 100 mL of normal saline over about 10 minutes. Procedure repeated with Zn-DTPA the following day. Two-day procedure repeated at an interval of one week or more for a total of six 2-day treatment sessions.
| Study group | Role | What they receive |
|---|---|---|
| Chelation with open-label Ca-DTPA and Zn-DTPA | Experimental | Six chelation treatments utilizing Ca-DTPA on day 1 and Zn-DTPA on day 2. Paired, 2-chelation day treatments will take place at intervals of one week or more. Receives: Drug: Calcium DTPA and Zinc DTPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
0-10 Scale of Pain Severity (Higher is more severe pain)
Rating scale of pain severity
Measured: 2 days before first DTPA treatment
0-10 Scale of Pain Severity
Rating scale of pain severity
Measured: 5-6 days after first 2-day DTPA treatment
0-10 Scale of Pain Severity
Rating scale of pain severity
Measured: 5-6 days after second 2-day DTPA treatment
0-10 Scale of Pain Severity
Rating scale of pain severity
Measured: 5-6 days after third 2-day DTPA treatment
0-10 Scale of Pain Severity
Rating scale of pain severity
Measured: 5-6 days after fourth 2-day DTPA treatment
0-10 Scale of Pain Severity
Rating scale of pain severity
Measured: 5-6 days after fifth 2-day DTPA treatment
0-10 Scale of Pain Severity
Rating scale of pain severity
Measured: 5-6 days after sixth 2-day DTPA treatment
0-10 Scale of Pain Severity
Rating scale of pain severity
Measured: One month after sixth 2-day DTPA treatment
Secondary outcomes (15)
Gadolinium Deposition Disease Symptom rating scale (higher number = symptom is more troubling0
Scale rating common symptoms seen in Gadolinium Deposition Disease
Measured: 2 days before first DTPA treatment treatment
Gadolinium Deposition Disease Symptom rating scale
Scale rating common symptoms seen in Gadolinium Deposition Disease
Measured: 5 to 6 days after first DTPA treatment treatment
Gadolinium Deposition Disease Symptom rating scale
Scale rating common symptoms seen in Gadolinium Deposition Disease
Measured: 5 to 6 days after third DTPA treatment treatment
Gadolinium Deposition Disease Symptom rating scale
Scale rating common symptoms seen in Gadolinium Deposition Disease
Measured: 5 to 6 days after fourth DTPA treatment treatment
Gadolinium Deposition Disease Symptom rating scale
Scale rating common symptoms seen in Gadolinium Deposition Disease
Measured: 5 to 6 days after fifth DTPA treatment treatment
Gadolinium Deposition Disease Symptom rating scale
Scale rating common symptoms seen in Gadolinium Deposition Disease
Measured: 5 to 6 days after sixth DTPA treatment treatment
Gadolinium Deposition Disease Symptom rating scale
Scale rating common symptoms seen in Gadolinium Deposition Disease
Measured: one month after sixth DTPA treatment treatment
Cognitive Function - Short Form 8a (Promis Item Bank v2.0) (Higher score = more cognitive complaint)
Measure of cognitive function
Measured: 2 days before first 2-day DTPA chelation
Cognitive Function - Short Form 8a (Promis Item Bank v2.0)
Measure of cognitive function
Measured: 5 to 6 after first 2-day DTPA chelation
Cognitive Function - Short Form 8a (Promis Item Bank v2.0)
Measure of cognitive function
Measured: 5 to 6 after second 2-day DTPA chelation
Cognitive Function - Short Form 8a (Promis Item Bank v2.0)
Measure of cognitive function
Measured: 5 to 6 after third 2-day DTPA chelation
Cognitive Function - Short Form 8a (Promis Item Bank v2.0)
Measure of cognitive function
Measured: 5 to 6 after fourth 2-day DTPA chelation
Cognitive Function - Short Form 8a (Promis Item Bank v2.0)
Measure of cognitive function
Measured: 5 to 6 after fifth 2-day DTPA chelation
Cognitive Function - Short Form 8a (Promis Item Bank v2.0)
Measure of cognitive function
Measured: 5 to 6 after sixth 2-day DTPA chelation
Cognitive Function - Short Form 8a (Promis Item Bank v2.0)
Measure of cognitive function
Measured: one month after sixth 2-day DTPA chelation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start11 Apr 2023 (estimated)
- Primary completion12 Sep 2024
- Study completion13 Sep 2024
Why it stopped: Could not recruit subjects quickly enough
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gadolinium Deposition DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Six adult patients aged 18 to 65 who meet diagnostic criteria for Gadolinium Deposition Disease and study inclusion criteria, and are free of exclusion criteria will be enrolled.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorrin M Koran, MD, Stanford University
- Investigators
- Lorrin M Koran, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359835
- Sponsor's protocol ID
- 65231
- Status last verified
- May 2025
- First submitted
- 26 Apr 2022
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Semelka RC, Ramalho M, Jay M, Hickey L, Hickey J. Intravenous Calcium-/Zinc-Diethylene Triamine Penta-Acetic Acid in Patients With Presumed Gadolinium Deposition Disease: A Preliminary Report on 25 Patients. Invest Radiol. 2018 Jun;53(6):373-379. doi: 10.1097/RLI.0000000000000453.
PubMed 29419708Maecker HT, Wang W, Rosenberg-Hasson Y, Semelka RC, Hickey J, Koran LM. An initial investigation of serum cytokine levels in patients with gadolinium retention. Radiol Bras. 2020 Sep-Oct;53(5):306-313. doi: 10.1590/0100-3984.2019.0075.
PubMed 33071374Maecker HT, Siebert JC, Rosenberg-Hasson Y, Koran LM, Ramalho M, Semelka RC. Dynamic Serial Cytokine Measurements During Intravenous Ca-DTPA Chelation in Gadolinium Deposition Disease and Gadolinium Storage Condition: A Pilot Study. Invest Radiol. 2022 Jan 1;57(1):71-76. doi: 10.1097/RLI.0000000000000803.
PubMed 34120127Goetzl EJ, Maecker HT, Rosenberg-Hasson Y, Koran LM. Altered Functional Mitochondrial Protein Levels in Plasma Neuron-Derived Extracellular Vesicles of Patients With Gadolinium Deposition. Front Toxicol. 2022 Jan 12;3:797496. doi: 10.3389/ftox.2021.797496. eCollection 2021.
PubMed 35295151Denmark D, Ruhoy I, Wittmann B, Ashki H, Koran LM. Altered Plasma Mitochondrial Metabolites in Persistently Symptomatic Individuals after a GBCA-Assisted MRI. Toxics. 2022 Jan 26;10(2):56. doi: 10.3390/toxics10020056.
PubMed 35202243
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DTPA Chelation for Symptoms After Gadolinium-assisted MRI
- ClinicalTrials.gov ID
- NCT05359835
- Acronym / sponsor ID
- 65231
- Conditions
- Gadolinium Deposition Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Could not recruit subjects quickly enough
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 11 Apr 2023 (estimated)
- Primary completion
- 12 Sep 2024 (actual)
- Study completion
- 13 Sep 2024 (actual)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims at gathering additional data on the safety and effectiveness of using intravenous administration of the drugs Ca-DTPA/Zn-DTPA to remove the heavy metal gadolinium from the bodies of patients who have retained it and developed symptoms of Gadolinium Deposition Disease following an MRI in which a gadolinium-containing contrast agent was utilized. The outcome data will include measures of symptom relief after as many as six paired Calcium-DTPA/Zinc-DTPA chelation treatments. The study also aims at gathering additional data before and after DTPA treatment regarding levels of certain cytokines in the patients' blood that have been reported to be abnormally elevated in patients with retained gadolinium.
Detailed description
This study aims at gathering additional data on the safety and effectiveness of using intravenous administration of the drug DTPA to remove the heavy metal gadolinium from the bodies of patients who have retained it and developed symptoms of Gadolinium Deposition Disease following an MRI in which a gadolinium-containing contrast agent was utilized. The outcome data will include measures of symptom relief, including chronic pain, skin changes, and cognitive complaints, after as many as six paired Calcium-DTPA/Zinc-DTPA chelation treatments. The study also aims at gathering additional data before and after DTPA treatment regarding levels of certain cytokines (chemical messengers) in the patients' blood that have been reported to be abnormally elevated in patients with retained gadolinium.
DTPA is approved as safe and effective by the federal Food and Drug Administration for the removal of certain radioactive heavy metals, has been in use for more than 60 years, is well tolerated, and has been safely used in three studies, that enrolled 25, 21 and 4 patients respectively who were diagnosed with Gadolinium Deposition Disease.Only the first study reported on symptom improvement, and noted that almost all patients experienced benefit after three paired Calcium-DTPA/Zinc-DTPA chelation treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Six adult patients aged 18 to 65 who meet diagnostic criteria for Gadolinium Deposition Disease and study inclusion criteria, and are free of exclusion criteria will be enrolled.
| Arm | Type | Receives |
|---|---|---|
| Chelation with open-label Ca-DTPA and Zn-DTPA | Experimental | Drug: Calcium DTPA and Zinc DTPASix chelation treatments utilizing Ca-DTPA on day 1 and Zn-DTPA on day 2. Paired, 2-chelation day treatments will take place at intervals of one week or more. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Adults aged 18 - 65 and able to give informed consent.
- Have had an MRI with contrast at least 3 months and less than 3 years before study enrollment.
- Have a 24-hour urine analysis 30 days or more post-MRI that documents abnormally high levels of gadolinium excretion.
- Exhibit within 30 days of the contrast-assisted MRI new onset of 3 or more of the following symptoms:
- Have met these Gadolinium Deposition Disease (GDD) diagnostic criteria for at least 3 months.
Key exclusion criteria (10 listed)
- Diagnosed by the patient's treating MD with an autoimmune or rheumatological disorder such as systemic lupus, rheumatoid arthritis or scleroderma;
- diagnosed by the patient's treating MD with a condition or conditions that could cause 3 or more of the 8 diagnostic symptoms of GDD;
- taking a medication or medications that could cause 3 or more of the 8 diagnostic symptoms of GDD;
- having a condition or conditions and taking a medication or medications that together might account for the presence of 3 or more of the diagnostic symptoms of GDD.
- Having Wilson's Disease, hemochromatosis, cancer (other than non-melanoma skin cancer), impaired kidney function, or heart disease compromising cardiac function or causing arrhythmia;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium DTPA and Zinc DTPAAlso: Diethylenetriaminepenta-acetateIntravenous administration of 2.5 mL (500 mg) of Ca-DTPA over one minute, followed by 900 mL of normal saline infusion over about 90 minutes, followed by 2.5 mL (500 mg) of Ca-DTPA over one minute, followed by infusion of the remaining 100 mL of normal saline over about 10 minutes. Procedure repeated with Zn-DTPA the following day. Two-day procedure repeated at an interval of one week or more for a total of six 2-day treatment sessions. | Drug | Chelation with open-label Ca-DTPA and Zn-DTPA |
Primary outcome
0-10 Scale of Pain Severity (Higher is more severe pain)
Time frame: 2 days before first DTPA treatment
Rating scale of pain severity
0-10 Scale of Pain Severity
Time frame: 5-6 days after first 2-day DTPA treatment
Rating scale of pain severity
0-10 Scale of Pain Severity
Time frame: 5-6 days after second 2-day DTPA treatment
Rating scale of pain severity
0-10 Scale of Pain Severity
Time frame: 5-6 days after third 2-day DTPA treatment
Rating scale of pain severity
0-10 Scale of Pain Severity
Time frame: 5-6 days after fourth 2-day DTPA treatment
Rating scale of pain severity
0-10 Scale of Pain Severity
Time frame: 5-6 days after fifth 2-day DTPA treatment
Rating scale of pain severity
0-10 Scale of Pain Severity
Time frame: 5-6 days after sixth 2-day DTPA treatment
Rating scale of pain severity
0-10 Scale of Pain Severity
Time frame: One month after sixth 2-day DTPA treatment
Rating scale of pain severity
15 secondary outcomes
Gadolinium Deposition Disease Symptom rating scale (higher number = symptom is more troubling0
Time frame: 2 days before first DTPA treatment treatment
Gadolinium Deposition Disease Symptom rating scale
Time frame: 5 to 6 days after first DTPA treatment treatment
Gadolinium Deposition Disease Symptom rating scale
Time frame: 5 to 6 days after third DTPA treatment treatment
Gadolinium Deposition Disease Symptom rating scale
Time frame: 5 to 6 days after fourth DTPA treatment treatment
Gadolinium Deposition Disease Symptom rating scale
Time frame: 5 to 6 days after fifth DTPA treatment treatment
Gadolinium Deposition Disease Symptom rating scale
Time frame: 5 to 6 days after sixth DTPA treatment treatment
Gadolinium Deposition Disease Symptom rating scale
Time frame: one month after sixth DTPA treatment treatment
Cognitive Function - Short Form 8a (Promis Item Bank v2.0) (Higher score = more cognitive complaint)
Time frame: 2 days before first 2-day DTPA chelation
Cognitive Function - Short Form 8a (Promis Item Bank v2.0)
Time frame: 5 to 6 after first 2-day DTPA chelation
Cognitive Function - Short Form 8a (Promis Item Bank v2.0)
Time frame: 5 to 6 after second 2-day DTPA chelation
Cognitive Function - Short Form 8a (Promis Item Bank v2.0)
Time frame: 5 to 6 after third 2-day DTPA chelation
Cognitive Function - Short Form 8a (Promis Item Bank v2.0)
Time frame: 5 to 6 after fourth 2-day DTPA chelation
Cognitive Function - Short Form 8a (Promis Item Bank v2.0)
Time frame: 5 to 6 after fifth 2-day DTPA chelation
Cognitive Function - Short Form 8a (Promis Item Bank v2.0)
Time frame: 5 to 6 after sixth 2-day DTPA chelation
Cognitive Function - Short Form 8a (Promis Item Bank v2.0)
Time frame: one month after sixth 2-day DTPA chelation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Background: PubMed 29419708Semelka RC, Ramalho M, Jay M, Hickey L, Hickey J. Intravenous Calcium-/Zinc-Diethylene Triamine Penta-Acetic Acid in Patients With Presumed Gadolinium Deposition Disease: A Preliminary Report on 25 Patients. Invest Radiol. 2018 Jun;53(6):373-379. doi: 10.1097/RLI.0000000000000453.
- Background: PubMed 33071374Maecker HT, Wang W, Rosenberg-Hasson Y, Semelka RC, Hickey J, Koran LM. An initial investigation of serum cytokine levels in patients with gadolinium retention. Radiol Bras. 2020 Sep-Oct;53(5):306-313. doi: 10.1590/0100-3984.2019.0075.
- Background: PubMed 34120127Maecker HT, Siebert JC, Rosenberg-Hasson Y, Koran LM, Ramalho M, Semelka RC. Dynamic Serial Cytokine Measurements During Intravenous Ca-DTPA Chelation in Gadolinium Deposition Disease and Gadolinium Storage Condition: A Pilot Study. Invest Radiol. 2022 Jan 1;57(1):71-76. doi: 10.1097/RLI.0000000000000803.
- Background: PubMed 35295151Goetzl EJ, Maecker HT, Rosenberg-Hasson Y, Koran LM. Altered Functional Mitochondrial Protein Levels in Plasma Neuron-Derived Extracellular Vesicles of Patients With Gadolinium Deposition. Front Toxicol. 2022 Jan 12;3:797496. doi: 10.3389/ftox.2021.797496. eCollection 2021.
- Background: PubMed 35202243Denmark D, Ruhoy I, Wittmann B, Ashki H, Koran LM. Altered Plasma Mitochondrial Metabolites in Persistently Symptomatic Individuals after a GBCA-Assisted MRI. Toxics. 2022 Jan 26;10(2):56. doi: 10.3390/toxics10020056.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorrin M Koran, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Calcium DTPA and Zinc DTPA in people with Gadolinium Deposition Disease, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
0-10 Scale of Pain Severity (Higher is more severe pain) (time frame: 2 days before first DTPA treatment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05359835, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.