Adult MedulloblastomaPhase 2NCT01869725

Comparative Study of Sensitivity of Ga-DOTATOC PET vs Octreoscan SPECT + CT

A Phase 2 study testing gallium Ga 68-edotreotide, positron emission tomography/computed tomography and indium In 111 pentetreotide in people with Adult Medulloblastoma and Childhood Medulloblastoma, run by Sue O'Dorisio at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 2 years and older
Conditions the study is for: Adult Medulloblastoma, Childhood Medulloblastoma, Neuroblastoma
What is being tested?: gallium Ga 68-edotreotide, positron emission tomography/computed tomography and indium In 111 pentetreotide
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 1 siteUnited States
Study dates: 1 Apr 2013to 26 Dec 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 2 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Signed informed consent
Biopsy proven neuroendocrine tumor, neuroblastoma, medulloblastoma, or other somatostatin receptor positive tumor
Off Sandostatin (octreotide acetate)-long acting release (LAR) > 4 weeks and off immediate release (subcutaneous) for 12 hrs prior to 68Ga-DOTATOC PET-CT
Karnofsky performance status or Lansky Play Scale status of >= 50 (or Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] equivalent)
Subject is male; or is a female who is either pre-menarchal, surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (> 1 years without menses), non-lactating, or of childbearing potential for whom a serum pregnancy test (with the results known prior to investigational product administration) is negative; a negative serum pregnancy test will be required for all female subjects with child bearing potential; if a false pregnancy test is suspected, e.g., perimenopausal condition, an obstetrician will be consulted to determine if she is/is capable of becoming pregnant
No therapy other than Sandostatin since last Octreoscan + diagnostic CT
Fresh frozen (recommended) or paraffin fixed (required) specimen of primary or metastases available for ribonucleic acid (RNA) and immunohistochemistry (IHC)

Who cannot join

Pregnancy or breast feeding
Surgical resection, chemotherapy, radiation therapy, or biologic therapy since last Octreoscan + CT; continuation of the same dose of Sandostatin-LAR or subcutaneous Sandostatin is allowed
Medical condition uncontrolled by treatment making completion of study unlikely
Weight more than 400 pounds (subjects who weigh more than 400 pounds will not be able to fit inside the imaging machines)
Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.)
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242

Other trials in United States

About this study

Official title: Comparator Study of 68Ga-DOTATOC PET/CT With Octreoscan + High-resolution, Contrast-enhanced CT for Diagnosis and Staging in Neuroendocrine Tumors and Other Somatostatin Receptor Positive Tumors

This clinical trial studies gallium Ga 68-edotreotide positron emission tomography (PET)/computed tomography (CT) compared with indium In 111 pentetreotide plus contrast-enhanced CT (or MRI) in diagnosing patients with neuroendocrine tumors and other somatostatin receptor positive tumors. Diagnostic procedures, such as gallium Ga 68-edotreotide PET/CT, may help find and diagnose somatostatin receptor positive neuroendocrine tumors. It is not yet known whether Ga 68-edotreotide PET/CT is as effective as indium In 111 pentetreotide plus contrast-enhanced CT (or MRI) in diagnosis and staging of patients with neuroendocrine tumors.

Read the detailed description

PRIMARY OBJECTIVES:

To compare efficacy of [68Ga]-DOTA-tyr3-Octreotide (68Ga-DOTATOC) (gallium Ga 68-edotreotide) PET/CT with Octreoscan (indium In 111 pentetreotide) + high-resolution, contrast-enhanced CT for diagnosis and staging in patients with somatostatin receptor expressing tumors.

OUTLINE:

Patients receive gallium Ga 68-edotreotide intravenously (IV) and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may also undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed.

Conditions: Adult Medulloblastoma, Childhood Medulloblastoma, Neuroblastoma, Neuroendocrine Tumor, Somatostatinoma
Being tested: gallium Ga 68-edotreotide, positron emission tomography/computed tomography, indium In 111 pentetreotide, computed tomography, contrast-enhanced magnetic resonance imaging
Keywords: Neuroendocrine Tumor, Ga-DOTATOC PET, Imaging
Medical subject headings: Medulloblastoma, Neuroblastoma, Neuroendocrine Tumors, Somatostatinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

gallium Ga 68-edotreotideDrug
Also called Ga-68 DOTA0-Tyr3-octreotide, Ga-68 DOTATOC
Given IV
positron emission tomography/computed tomographyProcedure or surgery
Undergo gallium Ga 68-edotreotide PET/CT scan
indium In 111 pentetreotideRadiation
Also called Indium-111 Octreotide DTPA, Indium-111-DTPA-D-Phe-1-octreotide, Indium-In 111 Pentetreotide, Indium-In-111-Pentetreotide
Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
computed tomographyProcedure or surgery
Also called tomography, computed
Undergo indium In 111 pentetreotide contrast-enhanced CT scan
contrast-enhanced magnetic resonance imagingProcedure or surgery
Also called Contrast-enhanced MRI
Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan

Study groups in NCT01869725
Study group	Role	What they receive
Diagnostic (gallium Ga 68-edotreotide PET/CT)	Experimental	Patients receive gallium Ga 68-edotreotide IV and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed. Receives: Drug: gallium Ga 68-edotreotide; Procedure: positron emission tomography/computed tomography; Radiation: indium In 111 pentetreotide; Procedure: computed tomography; Procedure: contrast-enhanced magnetic resonance imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology
Tumor lesions detected on 68Ga-DOTATOC PET/CT compared with tumor lesions detected on Octreoscan SPECT imaging plus high-resolution, contrast-enhanced CT.
Measured: Up to 6 months between the timing of the Octreoscan SPECT/CT plus high-resolution, contrast-enhanced CT and the time of the 68Ga-DOTATOC PET/CT (either imaging type may occur first)
Compare Sensitivity of 68Ga-DOTATOC PET/CT With Octreoscan
Compare sensitivity of 68Ga-DOTATOC PET/CT with Octreoscan + high-resolution, contrast-enhanced CT for diagnosis and staging in neuroendocrine tumors and other somatostatin receptor positive tumors
Measured: Up to 6 months
Compare Specificity of 68Ga-DOTATOC PET/CT With Octreoscan
Compare specificity of 68Ga-DOTATOC PET/CT with Octreoscan + high-resolution, contrast-enhanced CT for diagnosis and staging in neuroendocrine tumors and other somatostatin receptor positive tumors
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201326 Dec 2018

First posted5 Jun 2013 (estimated)
Study start1 Apr 2013
Primary completion26 Dec 2018
Study completion26 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Adult MedulloblastomaStudies of the same condition, open and under way.
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: Phase 2
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01869725
Sponsor's protocol ID: 201212736
Other IDs: NCI-2013-00936, P30CA086862, R01CA167632
Status last verified: Dec 2018
First submitted: 31 May 2013
Last updated: 22 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM)
Adult Glioblastoma, High Grade Glioma
Not yet recruiting
my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults
Sarcoma, Osteosarcoma
RecruitingPhase 1
Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms
Central Nervous System Neoplasms, Glioblastoma
RecruitingPhase 1
GPC2-CAR T Cell Therapy for Relapsed or Refractory Medulloblastoma in Children and Young Adults
Medulloblastoma, Central Nervous System Embryonal Tumor
Active, not recruitingPhase 1
Dose Escalation Study of CLR 131 in Pediatric Relapsed/Refractory Malignant Tumors Including Neuroblastoma and Sarcomas
Pediatric Solid Tumor, Pediatric Lymphoma

All Adult Medulloblastoma trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparator Study of 68Ga-DOTATOC PET/CT With Octreoscan + High-resolution, Contrast-enhanced CT for Diagnosis and Staging in Neuroendocrine Tumors and Other Somatostatin Receptor Positive Tumors
ClinicalTrials.gov ID: NCT01869725
Acronym / sponsor ID: 201212736
Conditions: Adult Medulloblastoma, Childhood Medulloblastoma, Neuroblastoma, Neuroendocrine Tumor, Somatostatinoma
Keywords: Neuroendocrine Tumor, Ga-DOTATOC PET, Imaging
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Sue O'DorisioUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 1 Apr 2013 (actual)
Primary completion: 26 Dec 2018 (actual)
Study completion: 26 Dec 2018 (actual)
First posted: 5 Jun 2013 (estimated)
Results: Posted 22 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To compare efficacy of [68Ga]-DOTA-tyr3-Octreotide (68Ga-DOTATOC) (gallium Ga 68-edotreotide) PET/CT with Octreoscan (indium In 111 pentetreotide) + high-resolution, contrast-enhanced CT for diagnosis and staging in patients with somatostatin receptor expressing tumors.

OUTLINE:

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Diagnostic (gallium Ga 68-edotreotide PET/CT)	Experimental	Drug: gallium Ga 68-edotreotide, Procedure: positron emission tomography/computed tomography, Radiation: indium In 111 pentetreotide, Procedure: computed tomography, Procedure: contrast-enhanced magnetic resonance imagingPatients receive gallium Ga 68-edotreotide IV and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed.

Who may qualify

Ages: 2 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

Signed informed consent
Biopsy proven neuroendocrine tumor, neuroblastoma, medulloblastoma, or other somatostatin receptor positive tumor
Off Sandostatin (octreotide acetate)-long acting release (LAR) > 4 weeks and off immediate release (subcutaneous) for 12 hrs prior to 68Ga-DOTATOC PET-CT
Karnofsky performance status or Lansky Play Scale status of >= 50 (or Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] equivalent)
Subject is male; or is a female who is either pre-menarchal, surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (> 1 years without menses), non-lactating, or of childbearing potential for whom a serum pregnancy test (with the results known prior to investigational product administration) is negative; a negative serum pregnancy test will be required for all female subjects with child bearing potential; if a false pregnancy test is suspected, e.g., perimenopausal condition, an obstetrician will be consulted to determine if she is/is capable of becoming pregnant

Key exclusion criteria (7 listed)

Pregnancy or breast feeding
Surgical resection, chemotherapy, radiation therapy, or biologic therapy since last Octreoscan + CT; continuation of the same dose of Sandostatin-LAR or subcutaneous Sandostatin is allowed
Medical condition uncontrolled by treatment making completion of study unlikely
Weight more than 400 pounds (subjects who weigh more than 400 pounds will not be able to fit inside the imaging machines)
Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.)

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
gallium Ga 68-edotreotideAlso: Ga-68 DOTA0-Tyr3-octreotide, Ga-68 DOTATOCGiven IV	Drug	Diagnostic (gallium Ga 68-edotreotide PET/CT)
positron emission tomography/computed tomographyUndergo gallium Ga 68-edotreotide PET/CT scan	Procedure or surgery	Diagnostic (gallium Ga 68-edotreotide PET/CT)
indium In 111 pentetreotideAlso: Indium-111 Octreotide DTPA, Indium-111-DTPA-D-Phe-1-octreotide, Indium-In 111 Pentetreotide, Indium-In-111-PentetreotideUndergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan	Radiation	Diagnostic (gallium Ga 68-edotreotide PET/CT)
computed tomographyAlso: tomography, computedUndergo indium In 111 pentetreotide contrast-enhanced CT scan	Procedure or surgery	Diagnostic (gallium Ga 68-edotreotide PET/CT)
contrast-enhanced magnetic resonance imagingAlso: Contrast-enhanced MRIUndergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan	Procedure or surgery	Diagnostic (gallium Ga 68-edotreotide PET/CT)

Primary outcome

Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology
Time frame: Up to 6 months between the timing of the Octreoscan SPECT/CT plus high-resolution, contrast-enhanced CT and the time of the 68Ga-DOTATOC PET/CT (either imaging type may occur first)
Tumor lesions detected on 68Ga-DOTATOC PET/CT compared with tumor lesions detected on Octreoscan SPECT imaging plus high-resolution, contrast-enhanced CT.
Compare Sensitivity of 68Ga-DOTATOC PET/CT With Octreoscan
Time frame: Up to 6 months
Compare sensitivity of 68Ga-DOTATOC PET/CT with Octreoscan + high-resolution, contrast-enhanced CT for diagnosis and staging in neuroendocrine tumors and other somatostatin receptor positive tumors
Compare Specificity of 68Ga-DOTATOC PET/CT With Octreoscan
Time frame: 6 months
Compare specificity of 68Ga-DOTATOC PET/CT with Octreoscan + high-resolution, contrast-enhanced CT for diagnosis and staging in neuroendocrine tumors and other somatostatin receptor positive tumors

Results and safety

Results posted to the registry on 22 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diagnostic (Gallium Ga 68-edotreotide PET/CT)	68	64

Primary outcome: Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology

Time frame: Up to 6 months between the timing of the Octreoscan SPECT/CT plus high-resolution, contrast-enhanced CT and the time of the 68Ga-DOTATOC PET/CT (either imaging type may occur first). Count of participants. Unit: Participants

Measure	Diagnostic (Gallium Ga 68-edotreotide PET/CT) n = 34
Sensitivity and Specificity for Ga-68-DOTATOC as Compared to Pathology: Total positive	28
Sensitivity and Specificity for Ga-68-DOTATOC as Compared to Pathology: False position	0
Sensitivity and Specificity for Ga-68-DOTATOC as Compared to Pathology: False negative	1
Sensitivity and Specificity for Ga-68-DOTATOC as Compared to Pathology: Total negative	5
Sensitivity and Specificity for OctreoScan as Compared to Pathology: Total positive	23
Sensitivity and Specificity for OctreoScan as Compared to Pathology: False position	0
Sensitivity and Specificity for OctreoScan as Compared to Pathology: False negative	6
Sensitivity and Specificity for OctreoScan as Compared to Pathology: Total negative	5

Population analysed: Patients with neuroendocrine tumor or other somatostatin receptor positive tumor

Primary outcome: Compare Sensitivity of 68Ga-DOTATOC PET/CT With Octreoscan

Time frame: Up to 6 months. Number. Unit: percentage of sensitivity

Measure	Diagnostic (Gallium Ga 68-edotreotide PET/CT) n = 34
Sensitivity of Ga-68-DOTATOC	96.55
Sensitivity of OctreoScan	79.31
Sensitivity of Conventional Imaging (CI)	82.24

Population analysed: Patients with neuroendocrine tumor or other somatostatin receptor positive tumor

Primary outcome: Compare Specificity of 68Ga-DOTATOC PET/CT With Octreoscan

Time frame: 6 months. Number. Unit: percentage of specificity

Measure	Diagnostic (Gallium Ga 68-edotreotide PET/CT) n = 34
Specificity of 68Ga-DOTATOC	100
Specificity of Octreoscan	100
Specificity of Conventional Imaging (CI)	47.82

Population analysed: Patients with neuroendocrine tumor or other somatostatin receptor positive tumor

Adverse events

Time frame: Adverse events were collected over 6 months at the following time points: 1) screening visit which occurred within 30 days of Ga-68 DOTATOC PET/CT 2) at scan 1 3) 1-7 days post scan 1 4) at scan 2 5) 1-7 days post scan 2. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diagnostic (Gallium Ga 68-edotreotide PET/CT)	0 of 68 (0%)	11 of 68 (16.2%)	1 of 68

Limitations and caveats (from the sponsor): Although 67/68 were eligible and received the 68Ga-DOTATOC PET scan, four patients did not receive the 111In-Octreotide SPECT scan. Of the 63 subjects who received both scans, 30 subjects did not receive the 111In-Octreotide SPECT scan within either the six months prior to or six months after the 68Ga-DOTATOC PET scan. This left only 34 subjects who could be fully evaluated for comparison of number of lesions found on both scans.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Adult Medulloblastoma

RecruitingPhase 1
A Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM)
Adult Glioblastoma, High Grade Glioma
Not yet recruiting
my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults
Sarcoma, Osteosarcoma
RecruitingPhase 1
Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms
Central Nervous System Neoplasms, Glioblastoma
RecruitingPhase 1
GPC2-CAR T Cell Therapy for Relapsed or Refractory Medulloblastoma in Children and Young Adults
Medulloblastoma, Central Nervous System Embryonal Tumor
Active, not recruitingPhase 1
Dose Escalation Study of CLR 131 in Pediatric Relapsed/Refractory Malignant Tumors Including Neuroblastoma and Sarcomas
Pediatric Solid Tumor, Pediatric Lymphoma

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.

M. Sue O' Dorisio, MD, PhD principal investigator

University of Iowa

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 7 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: finished, as of the sponsor's last update on 22 Sep 2021. 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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology (time frame: Up to 6 months between the timing of the Octreoscan SPECT/CT plus high-resolution, contrast-enhanced CT and the time of the 68Ga-DOTATOC PET/CT (either imaging type may occur first)). The study lists 3 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 NCT01869725.

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 22 Sep 2021.