An interventional study of Biopsy and Laboratory Biomarker Analysis in Lesion, Lung Cancer and Diagnoses Disease, sponsored by University of Arizona. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by University of Arizona · Not applicable, Interventional, and Diagnostic
Among 2,459 studies in Lung Neoplasms with a site in United States — 423 open to participants now, 644 under way, 53 of them phase 3. Lung Neoplasms · United States.
Among the 2,459 studies in Lung Neoplasms with a site in United States, this one is the 1,384th largest by enrollment of the 1,905 interventional ones, is one of 89 that started in 2017, is one of 522 with no phase, and was the 1,475th registered.
5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.
This study's enrollment of 21 is below the median of 60 across 3,656 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →423 of the 2,459 studies in Lung Neoplasms with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 996 Lung Neoplasms studies recruiting now, 683 (69%) set no upper age limit and 142 (14%) stop at 75 or younger; 45 take children under 18; 142 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →2,459 studies; the count open now beside each. This study's row is marked.
First in 1990; this study’s year is marked. 89 started in 2017.
Median enrollment 48 across the 1,905 interventional studies, 123 across the 442 observational. Of the 1,672 that completed or were terminated, 582 (35%) have results posted.
618 of 2,459 have an industry lead sponsor. The 10 most frequent:
University of Arizona is the lead sponsor of 476 studies on the registry; 88 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 30 (59%) have results posted.
University of Arizona has 9 studies filed under Lung Neoplasms — fewer than ten, so there is no comparison to draw.
246 of the studies in Lung Neoplasms with a site in United States that are under way reach primary completion within a year, 13 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07499674Phase 3Vergent Bioscience, Inc.Evaluation of the Safety and Efficacy of Abenacianine (VGT-309) to Identify Cancer in Subjects Undergoing Surgery for Cancer in the Lung | 2026-12 |
| NCT06151574Phase 3Boehringer IngelheimBeamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment | 2026-12-10 |
| NCT03637816Phase 3M.D. Anderson Cancer CenterAnamorelin Hydrochloride in Reducing Anorexia in Patients With Advanced Non-small Cell Lung Cancer | 2026-12-31 |
| NCT04093167Phase 3Canadian Cancer Trials GroupStudy of CTDNA Response Adaptive Immuno-Chemotherapy in Lung Cancer | 2026-12-31 |
| NCT03391869Phase 3M.D. Anderson Cancer CenterNivolumab and Ipilimumab With or Without Local Consolidation Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer | 2027-03-31 |
Among the 2,459 studies in Lung Neoplasms with a site in United States, from their registry updates:
This pilot early phase I trial studies how well real-time optical biopsy works in improving lung cancer diagnosis in patients undergoing lung biopsy. Real-time optical biopsy using confocal microscopy may improve the ability of physicians to diagnose lung cancer and accurately differentiate cancerous and benign lesions found during computed tomography screening.
PRIMARY OBJECTIVES:
I. Show that it is possible to distinguish lung cancer from benign lesions in ex vivo tissue samples using optical microscopy.
II. Test a proof-of-concept endoscopic instrument for imaging through a biopsy needle under computed tomography (CT) guidance on ex vivo tissue samples.
OUTLINE:
Patients undergo extraction of up to 3 additional lung biopsies from target lesions that are at least 2-3 cm in diameter using the 19 gauge SuperCore biopsy needle or the 20 gauge Rotax needle. The extracted tissue is imaged via confocal fluorescence microscopy using a variety of fluorescent contrast agents, such as, fluorescein sodium, methylene blue, or indocyanine green and then undergo hematoxylin and eosin processing.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergo extraction of up to 3 additional lung biopsies from target lesions that are at least 2-3 cm in diameter using the 19 gauge SuperCore biopsy needle or the 20 gauge Rotax needle. The extracted tissue is imaged via confocal fluorescence microscopy using a variety of fluorescent contrast agents, such as fluorescein sodium, methylene blue, indocyanine green and then undergo hematoxylin and eosin processing.
Procedure: Biopsy · Other: Laboratory Biomarker Analysis
Undergo lung biopsy
Also known as: Bx
Correlative studies
Diagnosis of ex vivo tissue samples for lung cancer or benign lesions using optical microscopy
The aim is to show that it is possible to distinguish lung cancer from benign lesions in ex vivo tissue samples using optical microscopy.
Time frame: At the time of biopsy
Imaging of ex vivo tissue samples using an endoscopic instrument
A proof-of-concept endoscopic instrument will be tested for imaging through a biopsy needle under computed tomography guidance on ex vivo tissue samples.
Time frame: At the time of biopsy
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jul 2017 to primary completion in Apr 2022, 57 months.
Of 864 non-industry interventional studies with no phase under Lung Neoplasms, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 68. This study's 57 months is above that.
Counting every sponsor, half of 915 studies reached it within 34 months; a quarter within 15 and three quarters within 67.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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