Breast CancerPhase 1NCT04138342
Topical Fluorescent Nanoparticles Conjugated Somatostatin Analog for Suppression and Bioimaging Breast Cancer
A Phase 1 study testing Quantum dots coated with veldoreotide in people with Breast Cancer and Skin Cancer, run by Al-Azhar University at 4 sites in 2 countries.
Trial summary
Breast cancer is a communal malignant disease between Saudi females, with a popularity of 21.8%. Since binding to somatostatin receptors (SSTR) induces no immunogenicity in vivo, somatostatin analog (veldoreotide) (VELD) may be suitable for delivering anti-cancer drugs to target and bioimaging the cancer cells. Read more about this study
- Who is it for?
- Ages 25 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Skin Cancer, Skin Diseases
- What is being tested?
- Quantum dots coated with veldoreotide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 15 Sep 2019to 13 Dec 2022
- Phase
- 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 25 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women, 25 to 60 years old.
- Breast biopsy within 60 days of registration (dosing) without proof of aggressive cancer in any specimen;
- Invasive breast cancer verified by histology of ER ≥ 10% (all test results should be checked and validated by the Pathology Department of the involved institution);
- Participants performed traditional regional radical therapy (modified or moderate radical mastectomy) with or without neoadjuvant/adjuvant chemotherapy or radiotherapy;
- Hemoglobin ≥ 90 g / L, neutrophils ≥ 1.5 × 109/L, platelets ≥ 75 × 109/L, AST and ALT ≤ 2.5 times the upper limit for natural (ULN), creatinine serum and urea nitrogen ≤ ULN.
Who cannot join
- Patients have previously received any other treatment or have begun adjuvant therapy.
- There are any comorbidities that may increase the level of sex hormones: pituitary adenomas, ovarian cancers, thymic carcinomas, etc.
- There are any comorbidities that may decrease sex hormone rates such as hyperthyroidism, hypothyroidism, cirrhosis, extreme obesity, Turner syndrome, lack of sex hormone synthetase, intracranial tumors, pituitary atrophy, etc. Patients have undergone and expected suppression of ovariectomy and ovarian activity.
- Patients have been diagnosed with other test drugs for the next 2 months.
- People of child-bearing age who are not willing to take effective contraception through therapy. Serious non-maligned tumor comorbidities can impair long-term follow-up.
- Patients have a family history of endometrial, reproductive or other gynecological malignancies. Transvaginal testing indicated more severe ovary defects and endometrial thickening.
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- Patients had thrombotic incidents such as a cerebrovascular injury (including a transient ischemic attack), deep venous thrombosis, and pulmonary embolism within 6 months of the start of the research.
- Serious insufficiency of the liver with Child-Pugh C class. Serious heart disease of New York Heart Association (NYHA) class ≥III. Patients are considered to be severely allergic to medications.
- Patients have a record of other malignancies over the last five years, with the exception of cutaneous basal cell carcinoma and cervical in situ carcinoma that has been healed. In other instances, investigators do not feel the topics are acceptable for study participants.
- Pregnant or lactating women (women of childbearing age should receive a negative pregnancy test within 14 days of the first dosage or, if pregnant, clinicians are required to undergo an ultrasound review to exclude childbirth).
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Saudi Arabia3 sites, 3 recruiting
- Recruiting
Buraidah Clinic
Buraidah, Al Qassim, 51171
Ahmed AH Abdellatif, Ph.D., +966507726856, a.abdellatif@qu.edu.sa
- Not yet recruiting
Faculty of Pharmacy
Buraidah, Al-Qassim Region, 51452
Ahmed AH Abdellatif, Ph.D., +966507726856, a.abdellatif@qu.edu.sa
- Not yet recruiting
Pharmaceutics dept., Faculty of Pharmacy, Qassim University
Buraidah, Al-Qassim Region, 51452
Ahmed AH Abdellatif, Ph.D., +966507726856, a.abdellatif@qu.edu.sa
Egypt1 site, 1 recruiting
- Not yet recruiting
Assiut Clinic
Asyut, 71526
Ahmed AH Abdellatif, PhD, +966507726856, a.abdellatif@qu.edu.sa
About this study
Official title: Fluorescent Nanoparticles Conjugated Long-acting Somatostatin Analog for Potent Suppression and Bioimaging Breast Cancer
Breast cancer is a communal malignant disease between Saudi females, with a popularity of 21.8%. Since binding to somatostatin receptors (SSTR) induces no immunogenicity in vivo, somatostatin analog (veldoreotide) (VELD) may be suitable for delivering anti-cancer drugs to target and bioimaging the cancer cells. This work aimed to deliver CdS/ZnS core-shell type quantum dots with carboxylic acid-functionalized (QDs-COOH) which is bioimaging and anticancer nanoparticles decorated VELD as SSTR agonist with anti-cancer activity in the form of topical cream to be deposited deep in the breast periphery.
Read the detailed description
QDs-COOH will be conjugated to the N terminal of phenylalanine of VELD when the reaction proceeded at pH 7. Topical cream will be adapted to deliver the conjugated system for maximum deposition through breast cancer cells using emulsion technology. The formulated nanoparticles and cream will be characterized for size using dynamic light scattering, drug-polymer interaction using FTIR, and morphology using SEM. Cellular uptake, permeability and cell viability study of the successful system of interest will be studied in cell culture models using different breast cell lines. Moreover, the in vivo study will also proceed on rats induced breast cancer. Finally, the nanoparticles loaded in a topical cream will be applied with clinical trial approvement on the human breast cancer for bioimaging and treating breast cancer. This work is to present a novel formulation for treatment and bioimaging of breast cancer which can deliver safely to the patients in a high dose to the affected tumor cells.
- Conditions
- Breast Cancer, Skin Cancer, Skin Diseases
- Being tested
- Quantum dots coated with veldoreotide, Topical approved placebo
- Medical subject headings
- Breast Neoplasms, Skin Neoplasms, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantum dots coated with veldoreotideDrug
Also called Topical cream
The active group will receive Quantum dots coated with veldoreotide in different topical dosage forms as an anti-cancer drug.
Topical approved placeboDrug
Also called Topical placebo gel or cream
The placebo group will receive topical FDA approved in different dosage forms as a negative control drug.
| Study group | Role | What they receive |
|---|---|---|
| Quantum dots nanoparticles group | Active comparator | A group of female volunteers infected with breast cancer will receive topical Quantum dots in different dosage forms. Receives: Drug: Quantum dots coated with veldoreotide |
| Topical approved placebo cream | Placebo comparator | A group of female volunteers infected with breast cancer will receive placebo cream as a negative control. Receives: Drug: Topical approved placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth inhibition was measured using the sulforhodamine B-based assay.
QDs-VELD have anticancer activity. This study will be determined by measuring the growth inhibition of anticancer activity for QDs-VELD.
Measured: 6 months
Amount of QDs-VELD fluorescent QDs-VELD in the breast periphery due to the fluorescence of QDs using flow cytometry.
The bioimaging effect for scintigraphy of breast cancer.
Measured: 6 months
Growth inhibition was measured by visual determination of breast cancer cells.
QDs-VELD have anticancer activity. This study will be determined by measuring the growth inhibition of anticancer activity for QDs-VELD.
Measured: 6 months
Secondary outcomes (1)
Stable topical quantum dots coated veldoreotide
Stability test will be studied for dosage forms. The test will carried out by standing the products on shelf life for three months. The stability test will be recorded using high performance liquid chromatography each thee days.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start15 Sep 2019
- Primary completion14 Jun 2021 (estimated)
- Study completion13 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed A. H. Abdellatif, Al-Azhar University
- Investigators
- Ahmed AH Abdellatif, PhD, Principal investigator, Qassim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138342
- Sponsor's protocol ID
- Qassim QDs-VELD
- Status last verified
- Oct 2019
- First submitted
- 7 Oct 2019
- Last updated
- 24 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The authors could not decide until now a plan to make individual participant data (IPD) available to other researchers.
Publications
Clive S, Gardiner J, Leonard RC. Miltefosine as a topical treatment for cutaneous metastases in breast carcinoma. Cancer Chemother Pharmacol. 1999;44 Suppl:S29-30. doi: 10.1007/s002800051114.
PubMed 10602908Doroshow JH. Redox modulation of chemotherapy-induced tumor cell killing and normal tissue toxicity. J Natl Cancer Inst. 2006 Feb 15;98(4):223-5. doi: 10.1093/jnci/djj065. No abstract available.
PubMed 16478735
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorescent Nanoparticles Conjugated Long-acting Somatostatin Analog for Potent Suppression and Bioimaging Breast Cancer
- ClinicalTrials.gov ID
- NCT04138342
- Acronym / sponsor ID
- Qassim QDs-VELD
- Conditions
- Breast Cancer, Skin Cancer, Skin Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 14 Jun 2021 (estimated)
- Study completion
- 13 Dec 2022 (estimated)
- First posted
- 24 Oct 2019 (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.
Breast cancer is a communal malignant disease between Saudi females, with a popularity of 21.8%. Since binding to somatostatin receptors (SSTR) induces no immunogenicity in vivo, somatostatin analog (veldoreotide) (VELD) may be suitable for delivering anti-cancer drugs to target and bioimaging the cancer cells. This work aimed to deliver CdS/ZnS core-shell type quantum dots with carboxylic acid-functionalized (QDs-COOH) which is bioimaging and anticancer nanoparticles decorated VELD as SSTR agonist with anti-cancer activity in the form of topical cream to be deposited deep in the breast periphery.
Detailed description
QDs-COOH will be conjugated to the N terminal of phenylalanine of VELD when the reaction proceeded at pH 7. Topical cream will be adapted to deliver the conjugated system for maximum deposition through breast cancer cells using emulsion technology. The formulated nanoparticles and cream will be characterized for size using dynamic light scattering, drug-polymer interaction using FTIR, and morphology using SEM. Cellular uptake, permeability and cell viability study of the successful system of interest will be studied in cell culture models using different breast cell lines. Moreover, the in vivo study will also proceed on rats induced breast cancer. Finally, the nanoparticles loaded in a topical cream will be applied with clinical trial approvement on the human breast cancer for bioimaging and treating breast cancer. This work is to present a novel formulation for treatment and bioimaging of breast cancer which can deliver safely to the patients in a high dose to the affected tumor cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quantum dots nanoparticles group | Active comparator | Drug: Quantum dots coated with veldoreotideA group of female volunteers infected with breast cancer will receive topical Quantum dots in different dosage forms. |
| Topical approved placebo cream | Placebo comparator | Drug: Topical approved placeboA group of female volunteers infected with breast cancer will receive placebo cream as a negative control. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women, 25 to 60 years old.
- Breast biopsy within 60 days of registration (dosing) without proof of aggressive cancer in any specimen;
- Invasive breast cancer verified by histology of ER ≥ 10% (all test results should be checked and validated by the Pathology Department of the involved institution);
- Participants performed traditional regional radical therapy (modified or moderate radical mastectomy) with or without neoadjuvant/adjuvant chemotherapy or radiotherapy;
- Hemoglobin ≥ 90 g / L, neutrophils ≥ 1.5 × 109/L, platelets ≥ 75 × 109/L, AST and ALT ≤ 2.5 times the upper limit for natural (ULN), creatinine serum and urea nitrogen ≤ ULN.
Key exclusion criteria (10 listed)
- Patients have previously received any other treatment or have begun adjuvant therapy.
- There are any comorbidities that may increase the level of sex hormones: pituitary adenomas, ovarian cancers, thymic carcinomas, etc.
- There are any comorbidities that may decrease sex hormone rates such as hyperthyroidism, hypothyroidism, cirrhosis, extreme obesity, Turner syndrome, lack of sex hormone synthetase, intracranial tumors, pituitary atrophy, etc. Patients have undergone and expected suppression of ovariectomy and ovarian activity.
- Patients have been diagnosed with other test drugs for the next 2 months.
- People of child-bearing age who are not willing to take effective contraception through therapy. Serious non-maligned tumor comorbidities can impair long-term follow-up.
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 |
|---|---|---|
| Quantum dots coated with veldoreotideAlso: Topical creamThe active group will receive Quantum dots coated with veldoreotide in different topical dosage forms as an anti-cancer drug. | Drug | Quantum dots nanoparticles group |
| Topical approved placeboAlso: Topical placebo gel or creamThe placebo group will receive topical FDA approved in different dosage forms as a negative control drug. | Drug | Topical approved placebo cream |
Primary outcome
Growth inhibition was measured using the sulforhodamine B-based assay.
Time frame: 6 months
QDs-VELD have anticancer activity. This study will be determined by measuring the growth inhibition of anticancer activity for QDs-VELD.
Amount of QDs-VELD fluorescent QDs-VELD in the breast periphery due to the fluorescence of QDs using flow cytometry.
Time frame: 6 months
The bioimaging effect for scintigraphy of breast cancer.
Growth inhibition was measured by visual determination of breast cancer cells.
Time frame: 6 months
QDs-VELD have anticancer activity. This study will be determined by measuring the growth inhibition of anticancer activity for QDs-VELD.
1 secondary outcome
Stable topical quantum dots coated veldoreotide
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2019.
- Results publication: PubMed 10602908Clive S, Gardiner J, Leonard RC. Miltefosine as a topical treatment for cutaneous metastases in breast carcinoma. Cancer Chemother Pharmacol. 1999;44 Suppl:S29-30. doi: 10.1007/s002800051114.
- Results publication: PubMed 16478735Doroshow JH. Redox modulation of chemotherapy-induced tumor cell killing and normal tissue toxicity. J Natl Cancer Inst. 2006 Feb 15;98(4):223-5. doi: 10.1093/jnci/djj065. No abstract available.
- Individual participant dataSharing planned: No. The authors could not decide until now a plan to make individual participant data (IPD) available to other researchers.
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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. This study is not recruiting at the moment.
Ahmed AH Abdellatif, PhD principal investigator
Qassim University
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Quantum dots coated with veldoreotide in people with Breast Cancer and Skin Cancer, run by Al-Azhar University at 4 sites in 2 countries.
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 5 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: status not confirmed, as of the sponsor's last update on 24 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Saudi Arabia, Egypt. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed AH Abdellatif, PhD (+966507726856 ext. 14618, a.abdellatif@qu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth inhibition was measured using the sulforhodamine B-based assay. (time frame: 6 months). 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 NCT04138342, which also lists 2 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 24 Oct 2019.