Soft Tissue Sarcoma (STS)Early Phase 15-ALARMSNCT07038278
5-AminoLevulinic Acid Aided Resection Margins in Sarcoma
A Early Phase 1 study testing 5-ALA in people with Soft Tissue Sarcoma (STS), run by University of Colorado, Denver at 1 site in United States.
Trial summary
The goal of this study is to learn if the intervention using a fluorescent agent 5-Aminolevulinic acid (5-ALA) to aid in the surgical approach to visualize the soft-tissue sarcoma (STS) during surgical resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma (STS)
- What is being tested?
- 5-ALA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Nov 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological confirmation of any subtype of primary Grades 2 or 3 soft tissue sarcomas (STS), per biopsy evaluation by a pathologist, according to Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC).
- Treatment decision includes planned surgical resection of STS.
- Age ≥18 years at time of consent.
- ECOG Performance Status 0 - 1.
- Hematology and blood chemistry parameters defined by:
- Leukocytes ≥ 3 × 10(9)/L
Show all 17Show fewer
- Absolute neutrophil count ≥ 1.5 × 10(9)/L
- Platelets ≥ 100 × 109/L, transfusions may be used to raise platelets to ≥ 100 × 10(9)/L (no washout required)
- Hemoglobin ≥ 9 g/dL, transfusions may be used to raise Hgb to ≥ 9 g/dL (no washout required)
- Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
- Aspartate transaminase (AST) / alanine transaminase (ALT) ≤ 2.5 × institutional ULN
- Creatinine within normal institutional limits OR creatinine clearance ≥ 30 mL/min/1.73 m2 for patients with creatinine above institutional ULN
- Participants of reproductive potential must agree to using adequate contraception (e.g., hormonal or barrier method of birth control; abstinence, an intrauterine device) for the duration of study participation (including dosing interruptions) and up to 42 days after end of study intervention; or be surgically sterilized (e.g., hysterectomy, tubal ligation, or vasectomy).
- Ability to swallow study agent.
- Ability to understand and willingness to sign an informed consent form.
- Ability and stated willingness to adhere to the study visit schedule and other protocol procedures/requirements for the duration of the study.
- Inclusion of Minorities and Other Underrepresented Populations Recruitment is open and encouraged to all genders, all minorities, and underrepresented populations. Although distributions may vary by disease type, our recruitment procedures have been developed to enroll participants who are representative of the respective target population.
Who cannot join
- Acute/chronic forms of porphyria.
- Uncontrolled, known concurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness.
- Patient has had chemotherapy, tumor resection, or radiation treatment ≤ 21 days prior to surgery.
- Simultaneous participation in another clinical trial ≤ 21 days of enrollment or during the duration of the study period.
- Planned use of other potentially phototoxic substances (e.g., St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides, quinolones and tetracyclines), and topical preparations containing aminolevulinic acid (5-ALA) for 24 hours during the perioperative period (defined as 24 hours prior to surgery to up to 24 hours post-surgery).
- Pregnant or planning to become pregnant during study participation or breastfeeding.
- Any condition that is in the opinion of the investigator would prohibit the understanding or rendering of informed consent or interfere with the participant's safety or compliance while on trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
Gregory Ottenberg, 1-303-724-0875, gregory.ottenberg@cuanschutz.edu
Steven Thorpe, MD, FACS
About this study
Official title: 5-AminoLevulinic Acid Aided Resection Margins in Sarcoma (5-ALARMS)
The goal of this study is to learn if the intervention using a fluorescent agent 5-Aminolevulinic acid (5-ALA) to aid in the surgical approach to visualize the soft-tissue sarcoma (STS) during surgical resection. 5-ALA goes through the blood stream and into the tumor tissue allowing it to light up when the surgeon uses a special light in the operating room. The technique is called 5-ALA fluorescence-guided surgery (FGS). The main question aims to answer if 5-ALA provide intraoperative fluorescent visualization of soft-tissue sarcoma versus surrounding tissue and demonstrate the efficacy of tumor and surgical margin resections by a gross and histological analysis of fluorescing and non-fluorescing samples immediately after removal. Participants will be asked to orally administer 5-ALA three to four hours prior to surgery in preoperative area.
- Conditions
- Soft Tissue Sarcoma (STS)
- Being tested
- 5-ALA
- Keywords
- soft tissue sarcoma, fluorescence
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-ALADrug
Also called Gleolan
5-ALA), also known by its brand name Gleolan, is an intermediate in the heme synthesis pathway that has been studied in tumor resections, especially in intracranial tumor resections. One advantage of intraoperative visualization with 5-ALA is the ability to directly visualize fluorescent tumor in the surgical field using a headset-mounted devices with fluorescence in the visual wavelength in real-time.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Patients diagnosed with Federation Nationale des Centres de Lutte Contre le Cancer (FNCLCC) Grade 2 or 3 soft tissue sarcomas who undergo surgical resection will be administered 20 mg/kg body weight of 5-ALA orally at 3-4 hours prior to anesthesia. Receives: Drug: 5-ALA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the feasibility of 5-ALA aided fluorescent visualization of soft tissue sarcomas versus surrounding tissues
Patients will receive 5-ALA administered in the preoperative area. Surgical resection of the soft tissue sarcoma will be done as per standard of care.
A fluorescent headset will be turned on at defined time points below and tumor fluorescence will be noted (yes or no):
- prior to skin incision
- once dissection has reached fascial layer
- when 50% of the tumor superficial-to-deep has been dissected
- following complete resection of the tumor.
Measured: From enrollment to 2 weeks
Surgeon survey results of intraoperative tumor fluorescence
Surgeons will fill out survey (yes or no) to answer following intraoperative assessment questions:
- if the tumor demonstrated fluorescence from 5-ALA
- Was the tumor fluorescence discernable from normal tissue.
- Did the 5-ALA use increase or decrease the resection amount
- Was the equipment was easy to use
Measured: perioperative/periprocedural
Secondary outcomes (7)
Demonstrate the efficacy of 5-ALA fluorescence in tumor resections by a histological analysis of non-fluorescing samples after tumor removal
The sarcoma tumor will then be hemisected immediately after resection in pathology lab.
The fluorescent headset will be used to identify areas of fluorescence in the tumor.
Multiple samples (3mm punch) will be taken from nonfluorescent areas and placed on slides:
Histologic analysis will evaluate for viable tumor cells (%). For this, Sensitivity will be considered as the proportion of cells who had viable tumor that fluoresced, with specificity as the proportion of cells that had non-viable tumor without fluorescence.
Measured: Day of Surgery
Demonstrate the efficacy of 5-ALA fluorescence in tumor resections by a histological analysis of fluorescing samples after tumor removal
Description: The sarcoma tumor will then be hemisected immediately after resection in pathology lab. The fluorescent headset will be used to identify areas of fluorescence in the tumor. Multiple samples (3mm punch) will be taken from these fluorescent areas in the tumor and placed on slides: Specific to the margins and include the relevant presence of fluorescence (yes/no), cancer cells(%). For this, Sensitivity will be considered as the proportion of cancerous cells that fluoresced, with specificity as the proportion of non-cancerous cells that did not.
Measured: Day of surgery
Demonstrate the efficacy of 5-ALA fluorescence in tumor resections by a histological analysis of fluorescing samples after tumor removal
The sarcoma tumor will then be hemisected immediately after resection in pathology lab.
The fluorescent headset will be used to identify areas of fluorescence in the tumor.
Multiple samples (3mm punch) will be taken from these fluorescent areas in the tumor and placed on slides:
These will be specific to the tumor and include the relevant presence of fluorescence (yes/no), viable tumor cells (%). For this, Sensitivity will be considered as the proportion of cells who had viable tumor that fluoresced, with specificity as the proportion of cells that had non-viable tumor without fluorescence.
Measured: Day of surgery
Determine oncologic outcomes for patients enrolled
Local recurrence free survival will be determined from time of surgery and with use of MRI with contrast
Measured: From enrollment to 2 years
Patient Reported Outcomes
Patient Reported Outcomes Measurement Information System (PROMIS) patient reported outcome measure.
Measured: From enrollment to 2 years
Patient Reported Outcomes
Toronto Extremity Salvage Score (TESS) patient reported outcome measure.
Measured: From enrollment to 2 years.
Patient Reported Outcomes
Visual Analog Scales (VAS) patient reported outcome measure.
Measured: From enrollment to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Sep 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue Sarcoma (STS)Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Thorpe, MD, FACS, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038278
- Sponsor's protocol ID
- 24-2149.cc
- Acronym
- 5-ALARMS
- Status last verified
- Jul 2026
- First submitted
- 9 Apr 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Teixidor P, Arraez MA, Villalba G, Garcia R, Tardaguila M, Gonzalez JJ, Rimbau J, Vidal X, Montane E. Safety and Efficacy of 5-Aminolevulinic Acid for High Grade Glioma in Usual Clinical Practice: A Prospective Cohort Study. PLoS One. 2016 Feb 17;11(2):e0149244. doi: 10.1371/journal.pone.0149244. eCollection 2016.
PubMed 26885645Giantini-Larsen AM, Kharas N, Pisapia D, Schwartz TH. Histology of high-grade glioma samples resected using 5-ALA fluorescent headlight and loupe combination. Acta Neurochir (Wien). 2023 Feb;165(2):567-575. doi: 10.1007/s00701-023-05496-8. Epub 2023 Jan 19.
PubMed 36656388Stummer W, Pichlmeier U, Meinel T, Wiestler OD, Zanella F, Reulen HJ; ALA-Glioma Study Group. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. Lancet Oncol. 2006 May;7(5):392-401. doi: 10.1016/S1470-2045(06)70665-9.
PubMed 16648043Schupper AJ, Baron RB, Cheung W, Rodriguez J, Kalkanis SN, Chohan MO, Andersen BJ, Chamoun R, Nahed BV, Zacharia BE, Kennedy J, Moulding HD, Zucker L, Chicoine MR, Olson JJ, Jensen RL, Sherman JH, Zhang X, Price G, Fowkes M, Germano IM, Carter BS, Hadjipanayis CG, Yong RL. 5-Aminolevulinic acid for enhanced surgical visualization of high-grade gliomas: a prospective, multicenter study. J Neurosurg. 2021 Oct 8;136(6):1525-1534. doi: 10.3171/2021.5.JNS21310. Print 2022 Jun 1.
PubMed 34624862Mahmoudi K, Garvey KL, Bouras A, Cramer G, Stepp H, Jesu Raj JG, Bozec D, Busch TM, Hadjipanayis CG. 5-aminolevulinic acid photodynamic therapy for the treatment of high-grade gliomas. J Neurooncol. 2019 Feb;141(3):595-607. doi: 10.1007/s11060-019-03103-4. Epub 2019 Jan 18.
PubMed 30659522Guder WK, Hartmann W, Buhles C, Burdack M, Busch M, Dunker N, Hardes J, Dirksen U, Bauer S, Streitburger A. 5-ALA-mediated fluorescence of musculoskeletal tumors in a chick chorio-allantoic membrane model: preclinical in vivo qualification analysis as a fluorescence-guided surgery agent in Orthopedic Oncology. J Orthop Surg Res. 2022 Jan 15;17(1):34. doi: 10.1186/s13018-022-02931-x.
PubMed 35033148Kenan S, Liang H, Goodman HJ, Jacobs AJ, Chan A, Grande DA, Levin AS. 5-Aminolevulinic acid tumor paint and photodynamic therapy for myxofibrosarcoma: an in vitro study. J Orthop Surg Res. 2020 Mar 5;15(1):94. doi: 10.1186/s13018-020-01606-9.
PubMed 32138774Endo M, Lin PP. Surgical margins in the management of extremity soft tissue sarcoma. Chin Clin Oncol. 2018 Aug;7(4):37. doi: 10.21037/cco.2018.08.10.
PubMed 30173528
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5-AminoLevulinic Acid Aided Resection Margins in Sarcoma (5-ALARMS)
- ClinicalTrials.gov ID
- NCT07038278
- Acronym / sponsor ID
- 5-ALARMS / 24-2149.cc
- Conditions
- Soft Tissue Sarcoma (STS)
- Keywords
- soft tissue sarcoma, fluorescence
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 26 Jun 2025 (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 goal of this study is to learn if the intervention using a fluorescent agent 5-Aminolevulinic acid (5-ALA) to aid in the surgical approach to visualize the soft-tissue sarcoma (STS) during surgical resection. 5-ALA goes through the blood stream and into the tumor tissue allowing it to light up when the surgeon uses a special light in the operating room. The technique is called 5-ALA fluorescence-guided surgery (FGS). The main question aims to answer if 5-ALA provide intraoperative fluorescent visualization of soft-tissue sarcoma versus surrounding tissue and demonstrate the efficacy of tumor and surgical margin resections by a gross and histological analysis of fluorescing and non-fluorescing samples immediately after removal. Participants will be asked to orally administer 5-ALA three to four hours prior to surgery in preoperative area.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: 5-ALAPatients diagnosed with Federation Nationale des Centres de Lutte Contre le Cancer (FNCLCC) Grade 2 or 3 soft tissue sarcomas who undergo surgical resection will be administered 20 mg/kg body weight of 5-ALA orally at 3-4 hours prior to anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histological confirmation of any subtype of primary Grades 2 or 3 soft tissue sarcomas (STS), per biopsy evaluation by a pathologist, according to Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC).
- Treatment decision includes planned surgical resection of STS.
- Age ≥18 years at time of consent.
- ECOG Performance Status 0 - 1.
- Hematology and blood chemistry parameters defined by:
Key exclusion criteria (7 listed)
- Acute/chronic forms of porphyria.
- Uncontrolled, known concurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness.
- Patient has had chemotherapy, tumor resection, or radiation treatment ≤ 21 days prior to surgery.
- Simultaneous participation in another clinical trial ≤ 21 days of enrollment or during the duration of the study period.
- Planned use of other potentially phototoxic substances (e.g., St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides, quinolones and tetracyclines), and topical preparations containing aminolevulinic acid (5-ALA) for 24 hours during the perioperative period (defined as 24 hours prior to surgery to up to 24 hours post-surgery).
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 |
|---|---|---|
| 5-ALAAlso: Gleolan5-ALA), also known by its brand name Gleolan, is an intermediate in the heme synthesis pathway that has been studied in tumor resections, especially in intracranial tumor resections. One advantage of intraoperative visualization with 5-ALA is the ability to directly visualize fluorescent tumor in the surgical field using a headset-mounted devices with fluorescence in the visual wavelength in real-time. | Drug | Intervention Group |
Primary outcome
Demonstrate the feasibility of 5-ALA aided fluorescent visualization of soft tissue sarcomas versus surrounding tissues
Time frame: From enrollment to 2 weeks
Patients will receive 5-ALA administered in the preoperative area. Surgical resection of the soft tissue sarcoma will be done as per standard of care. A fluorescent headset will be turned on at defined time points below and tumor fluorescence will be noted (yes or no): 1. prior to skin incision 2. once dissection has reached fascial layer 3. when 50% of the tumor superficial-to-deep has been dissected 4. following complete resection of the tumor.
Surgeon survey results of intraoperative tumor fluorescence
Time frame: perioperative/periprocedural
Surgeons will fill out survey (yes or no) to answer following intraoperative assessment questions: 1. if the tumor demonstrated fluorescence from 5-ALA 2. Was the tumor fluorescence discernable from normal tissue. 3. Did the 5-ALA use increase or decrease the resection amount 4. Was the equipment was easy to use
7 secondary outcomes
Demonstrate the efficacy of 5-ALA fluorescence in tumor resections by a histological analysis of non-fluorescing samples after tumor removal
Time frame: Day of Surgery
Demonstrate the efficacy of 5-ALA fluorescence in tumor resections by a histological analysis of fluorescing samples after tumor removal
Time frame: Day of surgery
Demonstrate the efficacy of 5-ALA fluorescence in tumor resections by a histological analysis of fluorescing samples after tumor removal
Time frame: Day of surgery
Determine oncologic outcomes for patients enrolled
Time frame: From enrollment to 2 years
Patient Reported Outcomes
Time frame: From enrollment to 2 years
Patient Reported Outcomes
Time frame: From enrollment to 2 years.
Patient Reported Outcomes
Time frame: From enrollment to 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Results publication: PubMed 26885645Teixidor P, Arraez MA, Villalba G, Garcia R, Tardaguila M, Gonzalez JJ, Rimbau J, Vidal X, Montane E. Safety and Efficacy of 5-Aminolevulinic Acid for High Grade Glioma in Usual Clinical Practice: A Prospective Cohort Study. PLoS One. 2016 Feb 17;11(2):e0149244. doi: 10.1371/journal.pone.0149244. eCollection 2016.
- Results publication: PubMed 36656388Giantini-Larsen AM, Kharas N, Pisapia D, Schwartz TH. Histology of high-grade glioma samples resected using 5-ALA fluorescent headlight and loupe combination. Acta Neurochir (Wien). 2023 Feb;165(2):567-575. doi: 10.1007/s00701-023-05496-8. Epub 2023 Jan 19.
- Results publication: PubMed 16648043Stummer W, Pichlmeier U, Meinel T, Wiestler OD, Zanella F, Reulen HJ; ALA-Glioma Study Group. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. Lancet Oncol. 2006 May;7(5):392-401. doi: 10.1016/S1470-2045(06)70665-9.
- Results publication: PubMed 34624862Schupper AJ, Baron RB, Cheung W, Rodriguez J, Kalkanis SN, Chohan MO, Andersen BJ, Chamoun R, Nahed BV, Zacharia BE, Kennedy J, Moulding HD, Zucker L, Chicoine MR, Olson JJ, Jensen RL, Sherman JH, Zhang X, Price G, Fowkes M, Germano IM, Carter BS, Hadjipanayis CG, Yong RL. 5-Aminolevulinic acid for enhanced surgical visualization of high-grade gliomas: a prospective, multicenter study. J Neurosurg. 2021 Oct 8;136(6):1525-1534. doi: 10.3171/2021.5.JNS21310. Print 2022 Jun 1.
- Results publication: PubMed 30659522Mahmoudi K, Garvey KL, Bouras A, Cramer G, Stepp H, Jesu Raj JG, Bozec D, Busch TM, Hadjipanayis CG. 5-aminolevulinic acid photodynamic therapy for the treatment of high-grade gliomas. J Neurooncol. 2019 Feb;141(3):595-607. doi: 10.1007/s11060-019-03103-4. Epub 2019 Jan 18.
- Results publication: PubMed 35033148Guder WK, Hartmann W, Buhles C, Burdack M, Busch M, Dunker N, Hardes J, Dirksen U, Bauer S, Streitburger A. 5-ALA-mediated fluorescence of musculoskeletal tumors in a chick chorio-allantoic membrane model: preclinical in vivo qualification analysis as a fluorescence-guided surgery agent in Orthopedic Oncology. J Orthop Surg Res. 2022 Jan 15;17(1):34. doi: 10.1186/s13018-022-02931-x.
- Results publication: PubMed 32138774Kenan S, Liang H, Goodman HJ, Jacobs AJ, Chan A, Grande DA, Levin AS. 5-Aminolevulinic acid tumor paint and photodynamic therapy for myxofibrosarcoma: an in vitro study. J Orthop Surg Res. 2020 Mar 5;15(1):94. doi: 10.1186/s13018-020-01606-9.
- Results publication: PubMed 30173528Endo M, Lin PP. Surgical margins in the management of extremity soft tissue sarcoma. Chin Clin Oncol. 2018 Aug;7(4):37. doi: 10.21037/cco.2018.08.10.
- Individual participant dataSharing planned: No
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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.
Steven Thorpe, MD, FACS principal investigator
University of Colorado, Denver
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 5-ALA in people with Soft Tissue Sarcoma (STS), run by University of Colorado, Denver 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 17 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: opening soon, as of the sponsor's last update on 22 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gregory Ottenberg (303-724-0875, gregory.ottenberg@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate the feasibility of 5-ALA aided fluorescent visualization of soft tissue sarcomas versus surrounding tissues (time frame: From enrollment to 2 weeks). The study lists 2 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 NCT07038278, which also lists 8 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 22 Jul 2026.